OPULENT PHARMA IMPURITY STOCK LIST (D-M)

OPULENT PHARMA IMPURITY STOCK LIST UPDATED OCTOBER 2019
Ground Floor, 8, Aagam Heritage, Opposite Someshwara Square, Vesu, Surat, Gujarat‐395007
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We shall reverst with competitive price and lead time for the same.
IMPURITY STOCK LIST CAS NUMBER
Product: DOXEPIN IMPURITIES
Doxepin EP Impurity A/ Doxepin Related Compound A (Doxepinone) 4504‐87‐4
Doxepin EP Impurity B/ Doxepin Related Compound B (Doxepinol) 4504‐88‐5
Doxepin EP Impurity C/ Doxepin Related Compound C (N‐Desmethyl (E)‐Doxepin) 4504‐96‐5
Doxepin N‐Oxide 22684‐91‐9
Doxepin Glucuronide 788790‐52‐3
N‐Desmethyl Doxepin HCl 2887‐91‐4
Product: DOXYLAMINE IMPURITIES
Doxylamine EP Impurity A (Doxylamine 4‐Pyridinyl Isomer) 873407‐01‐3
Doxylamine EP Impurity B 19490‐92‐7
Doxylamine EP Impurity C (Desmethyl Doxylamine) 1442‐21‐3
Doxylamine EP Impurity D (2‐Benzoylpyridine) 91‐02‐1
Doxylamine N‐Desmethyl Impurity 78868‐03‐8
Product: DRONEDARON IMPURITIES
Dronedaron Impurity A/ Dronadarone Amino Impurity 141644‐91‐9
Dronedaron Impurity C/ Dronedarone Related Compound D 141645‐16‐1
Dronedaron Impurity D/ Dronadarone Nitro Impurity 141645‐23‐0
Dronedaron Impurity E 141627‐42‐1
Dronedaron Des‐butyl Impurity/ Dronedarone Related Compound A 197431‐02‐0
Dronedarone Related Compound B (Des(methylsulfonyl) Dronedarone) 500791‐70‐8
Dronedaron N‐Oxide 1638586‐56‐7
Dronedarone N‐Formyl Impurity 1309381‐32‐5
Product: DROTAVERINE IMPURITIES

Drotaverine N‐oxide
Product: DULOXETINE HYDROCHLORIDE IMPURITIES
Duloxetine EP Impurity A (Duloxetine HCl (R)‐Isomer)
116539‐60‐7
910138‐96‐4
Duloxetine EP Impurity B (Duloxetine alcohol) 116539‐55‐0
Duloxetine EP Impurity C
949095‐98‐1
949096‐01‐9
Duloxetine EP Impurity D (α‐Napthol/ Naphthalen‐1‐ol) 90‐15‐3
Duloxetine EP Impurity E
1033803‐59‐6
1033719‐36‐6
Duloxetine EP Impurity F (Duloxetine 3‐Thiophene Isomer Racemate)
116817‐27‐7
116817‐28‐8
1104890‐90‐5
Duloxetine EP Impurity G 321‐38‐0
Duloxetine Related Compound H 199191‐66‐7
rac Duloxetine 3‐Thiophene Isomer 116817‐27‐7
rac Duloxetine 3‐Thiophene Isomer Oxalate 116817‐28‐8
Duloxetine Phenyl Carbamate 947686‐09‐1
Duloxetine Pthalimide 199191‐67‐8
Duloxetine Hydrochloride ‐ In house impurity
667465‐15‐8
645411‐16‐1
3‐(N, N‐Dimethylamino)‐1‐(2‐thienyl) propanone hydrochloride
13196‐35‐5
5424‐47‐5
N, N‐Dimethyl‐3‐hydroxy‐3‐(2‐thienyl)propanamine 116817‐84‐6
2‐Acetyl Thiophene 88‐15‐3
Duloxetine N‐Desmethyl Impurity 178273‐35‐3
Duloxetine Alpha hydroxy Impurity 940291‐11‐2
Duloxetine Dimethylaminopropanol Impurity/ Duloxetine Hydroxy Impurity 132335‐44‐5
Duloxetine N‐Methyl Oxalate
132335‐47‐8
132335‐46‐7

Duloxetine N‐Formyl 1243540‐89‐7
Duloxetine 2‐Naphthalenol Impurity 1346599‐09‐4
3‐Hydroxy‐N‐methyl‐3‐(2‐thienyl)propanamide 603996‐87‐8
Product: DUTASTERIDE IMPURITIES
Dutasteride EP impurity A 104239‐97‐6
Dutasteride EP Impurity B (Dutasteride Dimethylamide)
Dutasteride EP Impurity C (Dutasteride Ethyl Ester) 157307‐36‐3
Dutasteride EP impurity D (5,6‐Dehydro‐17α‐Dutasteride)
Dutateride EP Impurity E (17α‐Dutasteride) 1796930‐46‐5
Dutateride EP Impurity F 1365545‐42‐1
Dutasteride Methyl Ester Analog (Finasteride Methyl Ester Analog) 103335‐41‐7
17‐carboxamide Dutasteride 104214‐61‐1
Dihydro Dutasteride 164656‐22‐8
Desmethyl‐6,8,10‐triene Dutasteride 952718‐75‐1
5‐beta‐Dutasteride 957229‐52‐6
Product: EBASTINE IMPURITIES
Ebastine EP Impurity D 97928‐18‐2
Product: ECONAZOLE IMPURITIES
Econazole EP Impurity A/ Econazole Related Compound A (Miconazole EP Impurity A/ Fenticonazole EP Impurity A/
Deschlorobenzyl Econazole/ Tioconazole EP Impurity D/ Isoconazole EP Impurity B/ Isoconazole Nitrate EP Impurity A) 24155‐42‐8
Econazole Nitrate 24169‐02‐6
Product: EDARAVONE IMPURITIES
2‐(3‐Methyl‐5‐oxo‐1‐phenyl‐4,5‐dihydro‐1H‐pyrazol‐4‐yl)‐2‐sulfopropanoic acid 1357477‐99‐6
3‐Methyl‐1‐phenyl‐2‐pyrazoline‐5‐one 19735‐89‐8
Edaravone Dimer 82772‐85‐8
1‐hydroxy‐2‐(3‐methyl‐5‐oxo‐1‐phenyl‐4,5‐dihydro‐1H‐pyrazol‐4‐yl)propane‐2‐sulfonic acid 1242471‐40‐4
Product: EFAVIRENZ IMPURITIES
Efavirenz Related Compound A/ Efavirenz IP Impurity E (Efavirenz Amino Alcohol/ Efavirenz amino carbinol) 209414‐27‐7
Efavirenz Related Compound B 440124‐96‐9

Efavirenz Related Compound C/ Efavirenz IP Impurity F (Efavirenz Quinoline Analog) 391860‐73‐4
Efavirenz Racemic mixture 177530‐93‐7
Efavirenz Pentyne Analog 205755‐86‐8
Efavirenz Amino Alcohol Ethyl Carbamate 211563‐41‐6
Efavirenz IP Impurity H (Efavirenz Amino Alcohol Methyl Carbamate) 211563‐40‐5
Efavirenz Benzoyl Amino Alcohol Racemate 1189491‐03‐9
Efavirenz Methyl Impurity 353270‐76‐5
Product: ELIGLUSTAT IMPURITIES
(S)‐(+)‐2‐Phenylglycinol 20989‐17‐7
3,4‐Ethylenedioxybenzaldehyde 29668‐44‐8
Product: ELUXADOLINE IMPURITIES
(S)‐Benzyl (1‐Oxo‐1‐((2‐oxo‐2‐phenylethyl)amino)propan‐2‐yl)carbamate 864825‐19‐4
Product: EMPAGLIFLOZIN IMPURITIES
3‐Epi Empagliflozin/ Empagliflozin R‐Isomer 864070‐43‐9
Hydroxy Empagliflozin Impurity 1279691‐35‐8
Empagliflozin Bromo Impurity 915095‐89‐5
Methyl 5‐bromo‐2‐chlorobenzoate 251085‐87‐7
5‐Bromo‐2‐chlorobenzyl Alcohol 149965‐40‐2
5‐Bromo‐2‐chlorobenzaldehyde 189628‐37‐3
(R)‐Tetrahydrofuran‐3‐yl 4‐methylbenzenesulfonate 219823‐47‐9
Empagliflozin Methoxy impurity 872980‐38‐6
Empagliflozin Acetyl impurity 1079083‐63‐8
4‐[(5‐bromo‐2‐chlorophenyl)methyl]phenol 864070‐18‐8
(5‐bromo‐2‐chlorophenyl)(2‐fluorophenyl)methanone. 1715629‐30‐3
Product: EMTRICITABINE IMPURITIES
Emtricitabine IP Impurity A (Emtricitabine Carboxylic Acid) 1238210‐10‐0
Emtricitabine IP Impurity C (Desfluoro Emtricitabine/ Lamivudine) 134678‐17‐4
Emtricitabine IP Impurity E (Flucytosine/ 5‐Fluoro Cytosine) 2022‐85‐7
Emtricitabine IP Impurity J (2‐epi‐Emtricitabine) 145416‐34‐8

Emtricitabine Enantiomer 137530‐41‐7
Emtricitabine Sulfoxide 152128‐77‐3
5‐(4‐Amino‐5‐fluoro‐2‐oxo‐1(2H)‐pyrimidinyl)‐1,3‐oxathiolane‐2‐carboxylic acid 5‐methyl‐2‐(1‐methylethyl)cyclohexyl
ester 147126‐75‐8
Product: ENALAPRIL IMPURITIES
Enalapril EP Impurity B (Ramipril EP Impurity F/ Trandolapril ECPPA Impurity) 82717‐96‐2
Enalapril EP Impurity C (Enalapril Diacid/ Enalaprilate/ Enalaprilat)
76420‐72‐9
84680‐54‐6
Enalapril EP Impurity D (Enalapril Dione/ Enalapril Diketopiperazine) 115729‐52‐7
Enalapril EP Impurity E (Enalapril Phenylethyl Ester Analog)
Enalapril EP Impurity F (Enalapril Butyl Ester Analog)
76420‐77‐4
76391‐34‐9
Enalapril EP Impurity G/ Enalapril Cyclohexyl ECPPA Analog (Trandolapril ECPP alanine saturated analogue) 460720‐14‐3
Enalapril EP Impurity H (Enalapril Hexahydro Analog/ Enalapril Cyclohexyl Analog)
Enalapril EP Impurity I (Ondansetron EP Impurity E/ Imidazole/ Clotrimazole EP Impurity D/ Bifonazole EP Impurity C) 288‐32‐4
Enalaprilat Benzyl Ester 76391‐33‐8
Enalapril Diketopiperazine Acid 115623‐21‐7
Product: ENROFLOXACIN IMPURITIES
Enrofloxacin Impurity‐A (EP)/ Ciprofloxacin Impurity‐A (EP) (Fluoroquinolonic Acid) 86393‐33‐1
Enrofloxacin Impurity‐G (EP)/Ciprofloxacin Impurity‐C (EP) (Ciprofloxacin ethylenediamine compound)‐FREE BASE 103222‐12‐4
Enrofloxacin Impurity‐G (EP)/Ciprofloxacin Impurity‐C (EP) (Ciprofloxacin ethylenediamine compound)‐HCL SALT 528851‐31‐2
Product: ENTACAPONE IMPURITIES
Entacapone EP Impurity C 116313‐85‐0
Product: ENZALUTAMIDE IMPURITIES
Enzalutamide Impurity H 1332524‐01‐2
Enzalutamide Impurity I/ Enzalutamide Desfluoro impurity 915087‐16‐0
Enzalutamide Impurity J/ Enzalutamide Oxo Impurity 1242137‐18‐3

Enzalutamide Impurity 6 915087‐32‐0
Enzalutamide Carboxylic acid impurity 1242137‐15‐0
Enzalutamide N‐Desmethyl Impurity 1242137‐16‐1
2‐Fluoro‐N‐methyl‐4‐nitrobenzamide 915087‐24‐0
1,3‐bis(4‐Cyano‐3‐(trifluoromethyl)phenyl)thiourea 1839619‐50‐9
1,3‐bis(4‐Cyano‐3‐(trifluoromethyl)phenyl)urea 1895865‐11‐8
Product: EPLERENONE IMPURITIES
Eplerenone EP Impurity D 209253‐82‐7
Eplerenone Hydroxyacid 95716‐98‐6
Product: ERLOTINIB IMPURITIES
4,5‐Bis(2‐methoxyethoxy)‐2‐nitrobenzonitrile 236750‐65‐5
3‐Ethynylaniline 54060‐30‐9
Erlotinib Chloro Impurity 183322‐18‐1
2‐amino‐4,5‐bis(2‐methoxyethoxy)benzamide 236750‐62‐2
3‐Ethynylbenzenamine Hydrochloride 207226‐02‐6
(E)‐N'‐(2‐cyano‐4,5‐bis(2‐methoxyethoxy)phenyl)‐N,N‐dimethylformimidamide 950596‐59‐5
6,7‐bis(2‐methoxyethoxy)quinazolin‐4‐amine 1417161‐98‐8
Erlotinib Lactam Impurity 179688‐29‐0
Ethyl‐3,4‐dihydroxy benzoate
4,5‐Bis(2‐methoxyethoxy)anthranilic Acid Ethyl Ester 179688‐27‐8
Ethyl 3,4‐bis(2‐methoxyethoxy)benzoate 183322‐16‐9
3‐Ethynylaniline hydrochloride 207226‐02‐6
Ethyl 3,4‐Dihydroxybenzoate 3943‐89‐3
Product: ERTAPENEM IMPURITIES
Ertapenem Dimer Impurity 402955‐37‐7
Product: ERYTHROMYCIN IMPURITIES

Erythromycin EP Impurity B/ Erythromycin Related Compund N (Clarithromycin EP Impurity R/ N‐Desmethyl 6‐O‐
Desmethyl Clarithromycin/ N‐Desmethyl Erythromycin A) 992‐62‐1
Erythromycin EP impurity C (Erythromycin E) 41451‐91‐6
Erythromycin EP Impurity D (Anhydro Erythromycin A) 23893‐13‐2
Erythromycin EP Impurity E (Erythromycin A Enol ether) 33396‐29‐1
Erythromycin EP Impurity F (Pseudo Erythromycin A Enol Ether) 105882‐69‐7
Erythromycin EP Impurity H (Erythromycin A N‐oxide) 992‐65‐4
Erythromycin EP Impurity I (Erythralosamine) 546‐57‐6
Erythromycin EP Impurity L (N‐Formyl Erythromycin A) 127955‐44‐6
9‐Deoxo‐9a‐aza‐9a‐homo Erythromycin A (Azithromycin EP Impurity A/ N6‐Demethylazithromycin/
Desmethylazithromycin/ Azaerythromycin A/ Azathramycin) 76801‐85‐9
Erythromycin Oxime (Azithromycin Impurity S/ 9‐Erythromycin A Oxime/ Roxithromycin Impurity C/ Clarithromycin EP
Impurity J) 13127‐18‐9
Erythromycin A 9,11‐Imino Ether (Azithromycin Impurity R) 161193‐44‐8
Erythromycin A 6,9‐Imino Ether (Azithromycin Iminoether impurity) 99290‐97‐8
Product: ESCITALOPRAM IMPURITIES
EsCitalopram EP Impurity A (Citalopram EP Impurity A/ Citalopram Related Compound A/ Citalopram Amide) 64372‐56‐1
EsCitalopram EP Impurity D (Citalopram EP Impurity D/ Citalopram Related Compound D/ N‐Desmethyl Citalopram)
62498‐67‐3
97743‐99‐2
1188264‐72‐3
Escitalopram EP Impurity E/ Escitalopram Related Compound A (Citadiol/ Citalopram Dihydroxy Impurity)
103146‐25‐4
103146‐26‐5
128173‐53‐5
EsCitalopram EP Impurity F
Escitalopram EP Impurity G (Citalopram Dimethylaminobutanone/ Citalopram EP Impurity G/ Citalopram ketone) 1329745‐98‐3
Escitalopram EP Impurity H (Citalopram Related Compound E/ Citalopram N‐Oxide) 63284‐72‐0
EsCitalopram EP Impurity K (Citalopram R‐Isomer)
219861‐53‐7
128196‐02‐1

EsCitalopram EP Impurity L (Citalopram Desfluoro Impurity) 1346617‐30‐8
EsCitalopram EP Impurity M (Citalopram Carboxylic Acid Impurity/ Descyano Citalopram Carboxylic Acid) 440121‐09‐5
5‐Bromophthalide 64169‐34‐2
1,3‐dihydro‐1‐oxoisobenzofuran‐5‐carboxamide 85118‐25‐8
Escitalopram Impurity E ((S)‐Citalopram Fluorophenylmethanone Impurity)
1217846‐84‐8
1217846‐85‐9
Product: ESLICARBAZEPINE IMPURITIES
Oxcarbazepine 28721‐07‐5
Licarbazepine 29331‐92‐8
Eslicarbazepine Acetate R Isomer/ (R)‐Licarbazepine Acetate 186694‐45‐1
Product: ESOMEPRAZOLE IMPURITIES
Esomeprazole EP Impurity A (Omeprazole EP Impurity A/ Omeprazole Related Compound B) 37052‐78‐1
Esomeprazole EP Impurity B (Omeprazole EP Impurity B/ Desmethoxy Omeprazole) 110374‐16‐8
Esomeprazole EP Impurity C (Omeprazole EP Impurity C/ Omeprazole Sulfide/ Ufiprazole) 73590‐85‐9
Esomeprazole EP Impurity D/ Esomeprazole Related Compound A (Omeprazole EP Impurity D/ Omeprazole Sulfone) 88546‐55‐8
Esomeprazole EP Impurity E (Omeprazole EP Impurity E/ Omeprazole Related Compound E/ Omeprazole N‐Oxide) 176219‐04‐8
Esomeprazole EP Impurity F (Omeprazole R‐Isomer)
119141‐89‐8
161796‐77‐6
Esomeprazole Impurity H (Omeprazole EP Impurity H) 863029‐89‐4
Esomeprazole Impurity Sulfone N‐Oxide (Omeprazole EP Impurity I/ Omeprazole Related Compound I/ Omeprazole
Sulfone N‐Oxide) 158812‐85‐2
Product: ESTRADIOL IMPURITIES
Estradiol EP Impurity A (Estriol EP Impurity B/ Ethinylestradiol EP Impurity C/ Estrone) 53‐16‐7
Product: ESTRIOL IMPURITIES

Estriol EP Impurity B (Ethinylestradiol EP Impurity C/ Estradiol EP Impurity A/ Estrone) 53‐16‐7
Estriol EP Impurity D (Ethinylestradiol EP Impurity D/ Estradiol) 50‐28‐2
Product: ESZOPICLONE IMPURITIES
Eszopiclone Impurity C 148891‐53‐6
N‐Demethyl Eszopiclone
151776‐26‐0
300701‐71‐7
Product: ETHACRYNIC IMPURITIES
Ethacrynic Acid impurity A 1217‐67‐0
Ethacrynic Acid impurity B 95772‐54‐6
Product: ETHAMBUTOL IMPURITIES
Ethambutol EP Impurity A 96‐20‐8
Product: ETHINYLESTRADIOL IMPURITIES
Ethinylestradiol EP Impurity B/ Ethinyl Estradiol Related Compound B 1231‐96‐5
Ethinylestradiol EP Impurity C (Estriol EP Impurity B/ Estradiol EP Impurity A/ Estrone) 53‐16‐7
Ethinylestradiol EP Impurity D (Estriol EP Impurity D/ Estradiol) 50‐28‐2
Product: ETHIONAMIDE IMPURITIES
Ethionamide EP Impurity A 2196‐13‐6
Ethionamide EP Impurity B 100‐48‐1
Product: ETILEFRINE IMPURITIES
Etilefrine EP Impurity E 121‐71‐1
Product: ETODOLAC IMPURITIES
Etodolac EP Impurity A (8‐Desethyl Etodolac) 41339‐67‐7
Etodolac EP Impurity B (8‐Methyl Etodolac) 41340‐19‐6
Etodolac EP Impurity C/ Etodolac Related Compound A (1‐Methyl Etodolac) 109518‐50‐5
Etodolac EP Impurity J (Decarboxy Etodolac) 115066‐03‐0
Etodolac Impurity H (7‐Ethyltryptophol) 41340‐36‐7
3‐Oxopentanoic Acid 10191‐25‐0
2‐Ethylphenylhydrazine hydrochloride 19398‐06‐2

Product: ETOFENAMATE IMPURITIES
Etofenamate EP Impurity C 101‐23‐5
Product: ETORICOXIB IMPURITIES
Etoricoxib Desmethyl Impurity 202409‐31‐2
Etoricoxib Impurity D 221615‐75‐4
Etoricoxib Impurity 26 291756‐76‐8
Etoricoxib N1‐Oxide 325855‐74‐1
(E)‐2‐Chloro‐3‐imino‐N,N‐dimethylprop‐1‐en‐1‐amine Hydrochloride 1352804‐27‐3
(Z)‐3‐amino‐2‐chloroacrylaldehyde 221615‐73‐2
4‐(Chloromethyl)thioanisole 874‐87‐3
Product: EXEMESTANE IMPURITIES
Exemestane EP Impurity D/ Exemestane Related Compound C 897‐06‐3
Product: EZETIMIBE IMPURITIES
Ezetimibe Desfluoroaniline Analog 302781‐98‐2
Ezetimibe (SSS)‐Isomer 1593543‐07‐7
Ezetimibe meta‐Fluoroaniline Analog 1700622‐06‐5
Ezetimibe Ketone 191330‐56‐0
Ezetimibe (RRS)‐Isomer 163380‐16‐3
Ezetimibe (SSR)‐Isomer 1593543‐00‐0
Ezetimibe (RSR)‐Isomer 1376614‐99‐1
Ezetimibe Tetrahydropyran Impurity 1296129‐15‐1
Ezetimibe Ketone Benzyl Ether 190595‐65‐4
Ezetimibe Benzyl Ether Impurity 163222‐32‐0
Ezetimibe Open‐Ring Amide Impurity 1197811‐72‐5
Ezetimibe Benzyl Impurity 851860‐29‐2
Ezetimibe Benzyl Diol Impurity 1374250‐06‐2
Ezetimibe Deprotected Impurity/ SRS uncyclized ezetimibe impurity 1185883‐04‐2
Ezetimibe Open‐Ring Acid/ Ezetimibe Azetidinone Ring‐Opened Impurity 1391053‐63‐6
Ezetimibe 3‐Dehydroxy Impurity 204589‐58‐2
Ezetimibe (RRR)‐Isomer 1593542‐96‐1

Product: FAMCICLOVIR IMPURITIES
Famciclovir Related Compound A (6‐Deoxypenciclovir) 104227‐86‐3
Famciclovir Related Compound B (6‐Deoxypenciclovir Acetate/ Desacetyl Famciclovir) 104227‐88‐5
Famciclovir Related Compound E (2‐Aminopurine)
452‐06‐2
76124‐64‐6
Famciclovir Related Compound F 10310‐21‐1
Famciclovir Deoxy‐chloro Impurity
Famciclovir Dimethylaminopyridine Impurity (Valaciclovir EP Impurity G/ Valaciclovir Related Compound G) 1122‐58‐3
Product: FAMOTIDINE IMPURITIES
Famotidine EP Impurity A/ Famotidine Related Compound A 76833‐47‐1
Famotidine EP Impurity B/ Famotidine Related Compound B 89268‐62‐2
Famotidine EP Impurity C/ Famotidine Related Compound C
106433‐44‐7
76824‐17‐4
Famotidine EP Impurity D/ Famotidine Related Compound D 76824‐16‐3
Famotidine EP Impurity E/ Famotidine Related Compound E 129083‐44‐9
Famotidine EP Impurity F/ Famotidine Related Compound F (Famotidine Acid Impurity) 107880‐74‐0
Famotidine EP Impurity H (Famotidine Isothiourea Impurity)
106649‐96‐1
88046‐01‐9
Famotidine EP Impurity I 1020719‐36‐1
Famotidine EP Impurity J (Famotidine Acid Methyl Ester)
76824‐14‐1
1798006‐30‐0
Famotidine Related Compound A
124646‐10‐2
88061‐72‐7
Famotidine cyclic Impurity
Famotidine Sulfoxide 90237‐03‐9
Product: FEBANTEL IMPURITIES
1‐Nitro Febantel (Fenbendazole F‐1 compound) 63470‐85‐9
Product: FEBENDAZOLE IMPURITIES
Fenbendazole F‐1 compound (1‐Nitro Febantel) 63470‐85‐9

Product: FEBUXOSTAT IMPURITIES
Febuxostat Dicarboxylic Acid Impurity 1239233‐87‐4
Febuxostat Amide Impurity 1239233‐86‐3
4‐Cyanophenol 767‐00‐0
Febuxostat Descyano Hydroxy Ethyl Ester 161797‐99‐5
Ethyl 2‐(3‐formyl‐4‐isobutoxyphenyl)‐4‐methylthiazole‐5‐carboxylate 161798‐03‐4
Febuxostat Ethyl Ester 160844‐75‐7
Febuxostat 4‐Hydroxy Ethyl Ester 161798‐02‐3
Ferbuxostat Diethyl Ester Impurity 1643131‐93‐4
Febuxostat Acid Ester Impurity 2095166‐41‐7
Febuxostat sec‐Butyl Ether Acid Impurity 1335202‐59‐9
Febuxostat Butyl Ether Analog 1657014‐33‐9
Febuxostat Isopropyl Ether Analog 144060‐52‐6
Product: FELBAMATE IMPURITIES
Phenylpropanediol 1570‐95‐2
Product: FELBINAC IMPURITIES
Felbinac EP Impurity A (4‐Acetyl biphenyl) 92‐91‐1
Felbinac EP Impurity B (Fenbufen EP Impurity C/ Biphenyl ) 92‐52‐4
Product: FELODIPINE IMPURITIES
Felodipine EP Impurity A (Dehydro Felodipine) 96382‐71‐7
Felodipine EP Impurity B (Felodipine Dimethyl Ester) 91189‐59‐2
Felodipine EP Impurity C (Felodipine Diethyl Ester/ Nemadipine B) 79925‐38‐5
Product: FENBUFEN IMPURITIES
Fenbufen EP Impurity C (Felbinac EP Impurity B/ Biphenyl ) 92‐52‐4
Product: FENOFIBRATE IMPURITIES
Fenofibrate EP Impurity A/ Fenofibrate Related Compound A 42019‐78‐3
Fenofibrate EP Impurity B/ Fenofibrate Related Compound B (Fenofibric Acid) 42017‐89‐0
Fenofibrate EP Impurity C 217636‐47‐0
Fenofibrate EP Impurity D (Fenofibrate Methyl Ester Analog) 42019‐07‐8
Fenofibrate EP Impurity E (Fenofibrate Ethyl Ester Analog) 42019‐08‐9

Fenofibrate EP Impurity F 154356‐96‐4
Fenofibrate EP Impurity G/ Fenofibrate Related Compound C 217636‐48‐1
Fenofibric Acid 1‐Carboxyl‐1‐methylethyl Ester 1797121‐54‐0
Choline Fenofibrate 856676‐23‐8
Product: FENTANYL IMPURITIES
Ethyl (2‐Amino‐4‐thiazolyl)acetate 53266‐94‐7
Product: FENTICONAZOLE IMPURITIES
Fenticonazole EP Impurity A (Econazole EP Impurity A/ Econazole Related Compound A/ Miconazole EP Impurity A/
Deschlorobenzyl Econazole/ Tioconazole EP Impurity D/ Isoconazole EP Impurity B/ Isoconazole Nitrate EP Impurity A) 24155‐42‐8
Product: FESOTERODINE IMPURITIES
3‐(3‐Aminopropyl)benzoic Acid 1346604‐68‐9
Fesoterodine Fumarate Ester 1254942‐29‐4
Fesoterodine O‐Isobutyryl Impurity 1208313‐13‐6
Fesoterodine Diol (R)‐Isomer (Tolterodine 5‐Hydroxymethyl Analog (R)‐Isomer) 207679‐81‐0
Fesoterodine Isobutyrate Aldehyde Impurity 1435768‐96‐9
(S)‐3‐(3‐(diisopropylamino)‐1‐phenylpropyl)‐4‐hydroxybenzaldehyde 214601‐12‐4
Product: FEXOFENADINE HYDROCHLORIDE IMPURITIES
Fexofenadine EP Impurity A/ Fexofenadine Related Compound A (Fexofenadinone) 76811‐98‐8
Fexofenadine EP Impurity B/ Fexofenadine Related Compound B (Meta‐Fexofenadine) 479035‐75‐1
Fexofenadine EP Impurity C/ Fexofenadine Related Compound C (Decarboxy Fexofenadine) 185066‐37‐9
Fexofenadine EP Impurity D (Fexofenadine Methyl Ester) 154825‐96‐4
Fexofenadine EP Impurity E 115‐46‐8
Fexofenadine EP Impurity G 1187954‐57‐9
Fexofenadine Keto ester/ 1‐Oxo Fexofenadine Methyl Ester
154477‐55‐1
169280‐33‐5
Fexofenadine Cyclopropyl acid Impurity 162096‐54‐0
Benzene aceticacid,4‐(4‐hydroxy‐1‐oxobutyl)‐alpha,alpha‐dimethyl‐,methylester 394222‐30‐1
Fexofenadine Impurity D/ 4‐[4‐[4‐(Hydroxydiphenylmethyl)‐1‐piperidinyl]‐1‐butyn‐1‐yl]‐α,α‐dimethyl‐benzeneacetic
Acid 832088‐68‐3
4‐(4‐Chloro‐1‐oxobutyl)‐α,α‐dimethylbenzeneacetic Acid Methyl Ester 154477‐54‐0
Product: FINASTERIDE IMPURITIES

Finasteride EP Impurity A/ Finasteride Related Compund A (1,2‐Dihydro Finasteride) 98319‐24‐5
Finasteride EP Impurity B/ Finasteride Related Compund D (Dutasteride Methyl Ester Analog/Finasteride Methyl Ester
Analog) 103335‐41‐7
Finasteride EP Impurity C/ Finasteride Related Compund B (5,6‐Dehydro Finasteride) 1329611‐51‐9
5β‐Finasteride 140375‐22‐0
Finasteride Dihydro Carboxylic Acid 103335‐55‐3
Product: FINGOLIMOD IMPURITIES
Fingolimod Palmitate Amide 1242271‐26‐6
Fingolimod sterate Amide 1242271‐27‐7
Fingolimod mono O‐Acetyl 1807973‐92‐7
Fingolimod Decyl Impurity (Fingolimod C10 Homolog) 780729‐32‐0
2‐(4‐Decylphenethyl)‐2‐nitropropane‐1,3‐diol
1‐(4‐Decylphenyl)‐3‐nitropropan‐1one
Fingolimod Hexyl Impurity (Fingolimod C6 Homolog) 1201794‐93‐5
2‐(4‐hexylphenethyl)‐2‐nitropropane‐1,3‐diol
1‐(4‐hexylphenyl)‐3‐nitropropan‐1‐one
3‐Nitro‐1‐(4‐octylphenyl)propan‐1‐one 899822‐97‐0
Triacetylated Fingolimod 162358‐09‐0
1‐(4‐heptylphenyl)‐3‐nitropropan‐1‐one
Fingolimod Heptyl Analog
745767‐97‐9
162361‐44‐6
Vinyl Fingolimod 24993‐87‐1
Fingolimod EP Impurity E (Fingolimod ortho‐octylphenyl Impurity/ Fingolimod 2‐Phenethyl Analog) 851039‐25‐3
Fingolimod EP Impurity F Fingolimod meta‐octylphenyl Impurity/ Fingolimod 3‐Phenethyl Analog) 851039‐24‐2
Fingolimod Deshydroxymethyl N‐Acetyl Impurity 177259‐52‐8
Fingolimod Nitro Impurity 374077‐88‐0
Fingolimod N,N‐Dimethyl Impurity 1404433‐87‐9
Fingolimod N‐Methyl Impurity 1404233‐80‐2

Fingolimod Nonyl Impurity/ Fingolimod C9 Homolog 296282‐40‐1
Fingolimod 4‐Hydroxy Impurity 268557‐51‐3
N‐Ethyl Fingolimod 1402793‐28‐5
Fingolimod Methyl Impurity 162361‐47‐9
Fingolimod Impurity C 296282‐46‐7
Fingolimod 1‐Hydroxy Nitro Impurity 899822‐99‐2
Fingolimod EP Impurity I 249289‐10‐9
Fingolimod N‐Acetyl Diethyl Ester 162358‐08‐9
Fingolimod EP Impurity C 746594‐44‐5
2‐acetamido‐2‐phenethyl‐propanedioate 5463‐92‐3
n‐Octylbenzene 2189‐60‐8
4'‐n‐Octylacetophenone 10541‐56‐7
4’‐Deoctyl 4’‐(1‐Hydroxyoctyl) Fingolimod 296282‐43‐4
1‐(3‐nitropropyl)‐4‐octylbenzene 374077‐87‐9
Product: FLAVOXATE IMPURITIES
Flavoxate EP Impurity A/ Flavoxate Related Compound A 3468‐01‐7
Flavoxate EP Impurity B/ Flavoxate Related Compound C 35888‐94‐9
Flavoxate EP Impurity C 1286165‐14‐7
Product: FLECAINIDE IMPURITIES
Flecainide EP Impurity B 22990‐77‐8
Flecainide EP Impurity D 35480‐52‐5
Flecainide EP Impurity E 57415‐36‐8
Flecainide Related Compound A
Product: FLUCLOXACILLIN IMPURITIES
Flucloxacillin EP Impurity B (Flucloxacillin Penilloic Acid) 1276016‐89‐7
Flucloxacillin EP Impurity C (Cloxacillin EP Impurity C/ Ampicillin EP Impurity A/ Amoxicillin EP Impurity A/ Amoxicillin
Related Compound A/ Piperacillin EP Impurity H/ Sulbactam EP Impurity B/ 6‐Aminopenicillanic Acid) 551‐16‐6
(5R)‐Flucloxacillin Penilloic Acid 42947‐70‐6
Product: FLUCONAZOLE IMPURITIES

Fluconazole EP Impurity A (Fluconazole Triazole Isomer) 89429‐59‐4
Fluconazole EP Impurity B/ Fluconazole Related Compound A 871550‐15‐1
Fluconazole EP Impurity C/ Fluconazole Related Compound C 514222‐44‐7
Fluconazole EP Impurity D/ Fluconazole Related Compound B (2‐Desfluoro Fluconazole) 81886‐51‐3
Fluconazole EP Impurity E (Fluconazole Keto Impurity/ Voriconazole EP Impurity A/ Voriconazole Related Compound C/
Voriconazole Triazole Acetophenone Impurity) 86404‐63‐9
Fluconazole EP Impurity F (Fluconazole Diol Impurity) 118689‐07‐9
Fluconazole EP Impurity G (Fluconazole Epoxide Impurity) 86386‐76‐7
Fluconazole EP Impurity H (Fluconazole Bromo Impurity) 150194‐52‐8
Fluconazole Impurity 5 154534‐83‐5
Product: FLUDARABINE IMPURITIES
Fludarabine Phosphate EP Impurity D 700‐49‐2
Product: FLUNARIZINE IMPURITIES
Flunarizine EP Impurity A 27469‐60‐9
Flunarizine EP Impurity B 27064‐96‐6
Product: FLUOROURACIL IMPURITIES
Fluorouracil EP Impurity A (Barbituric acid) 67‐52‐7
Fluorouracil EP Impurity B (Isobarbituric acid) 496‐76‐4
Fluorouracil EP Impurity C (Lamivudine EP Impurity F/ Uracil) 66‐22‐8
Fluorouracil EP Impurity D (5‐Methoxyuracil) 6623‐81‐0
Fluorouracil EP Impurity E (5‐Chlorouracil) 1820‐81‐1
Product: FLUOXETINE IMPURITIES
Fluoxetine EP Impurity A 42142‐52‐9
Fluoxetine EP Impurity B/ Fluoxetine Related Compound B
30684‐07‐2
23580‐89‐4
Fluoxetine Related Compound A (Meta Fluoxetine/ Fluoxetine Impurity C)
56161‐72‐9
79088‐29‐2
Fluoxetine related compound C (Fluoxetine Succinamic Acid) 1026723‐45‐4

N‐Formylfluoxetine 199188‐97‐1
p‐Nitrobenzal Difluoride 29848‐57‐5
N‐methyl‐3‐phenylprop‐2‐en‐1‐amine 60960‐88‐5
Fluoxetine N‐β‐D‐Glucuronide 96735‐71‐6
Product: FLUPIRTINE IMPURITIES
Flupirtine Desfluoro Impurity
736866‐91‐4
21630‐56‐8
Flupirtine Impurity C/ 2‐Amino‐6‐(benzylamino)‐3‐nitropyridine 21626‐43‐7
Flupirtine Maleate Impurity A/ Flupirtine 2‐Oxo Impurity 951624‐49‐0
Product: FLUPROSTENOL IMPURITIES
15‐keto Fluprostenol isopropyl ester 404830‐45‐1
Product: FLURBIPROFEN IMPURITIES
Flurbiprofen EP Impurity A (Biprofen) 6341‐72‐6
Flurbiprofen EP Impurity B 1797883‐74‐9
Methyl Flurbiprofen 66202‐86‐6
Product: FLUTAMIDE IMPURITIES
Flutamide EP Impurity C 13312‐12‐4
Flutamide EP Impurity E 1939‐27‐1
Product: FLUTICASONE IMPURITIES
Fluticasone EP Impurity A (Fluticasone Carboxylic Acid Propionate) 65429‐42‐7
Fluticasone EP impurity B/ Fluticasone Related Compound A (Fluticasone Sulfenic Acid Propionate) 948566‐12‐9
Fluticasone EP Impurity C/ Fluticasone Related Compound C (Fluticasone Acetate Analog) 80474‐24‐4
Fluticasone EP Impurity D/ Fluticasone Related Compound D (Fluticasone Methylsulphanyl Analog/ Ticabesone
Propionate) 73205‐13‐7
Fluticasone EP Impurity F (11‐Oxo Fluticasone Propionate) 1219174‐94‐3
Fluticasone EP Impurity G/ Fluticasone Related Compound E (Fluticasone Dimer Impurity) 220589‐37‐7
Fluticasone Related Compound B (Fluticasone Trioxo Impurity) 219719‐95‐6

Product
Fluvasta
Fluvasta
Fluvasta
Product
Fluvoxa
Fluvoxa
Fluvoxa
Fluvoxa
Fluvoxa

Fluvoxa
Fluvoxa
Fluvoxa
Fluvoxa
valeroph
Product
Folic Ac
Folic Ac
Folic Ac
Product
Formote
Formote
Product
Fosfomy
t: FLUVASTAT
atin EP Impurity
atin EP Impurity
atin Related Com
t: FLUVOXAMI
mine EP Impur
mine EP Impur
mine EP Impur
mine EP Impur
mine EP Impur
mine EP Impur
mine EP Impur
mine EP Impur
mine Amide Im
henone
t: FOLIC ACID I
id EP Impurity
id EP Impurity
id Impurity B
t: FORMOTERO
erol EP Impurit
erol EP Impurit
t: FOSFOMYCIN
ycin EP Impurit
IN IMPURITIE
y C / Fluvastati
y D (3‐Hydroxy
mpound B
INE IMPURITIE
rity A (Desmeth
rity B
rity C (N‐(2‐Suc
rity D (Fluvoxam
rity F (Aminoeth
rity G (Desmeth
rity I (Fluvoxam
rity K (Aminoet
mpurity
IMPURITIES
A (Methotrexat
B
OL IMPURITIE
ty A
ty B
N IMPURITIES
ty A
S
in N‐Ethyl Analo
y‐5‐Keto Fluvas
ES
hoxy Fluvoxami
ccinyl) Fluvoxam
mine Valerophe
hyl fluvoxamine
hyl Fluvoxamine
mine oxime)
hyl desmethoxy
te EP Impurity
S

og
tatin)
ne)
mine)
enone analog/ F
e)
e)
y fluvoxamine)
K)
Fluvoxketone)

77
93
11
12

12
91
25
61
12
19
61
88

10

42
10
35

15
12

13
11
79995‐42‐5
3936‐64‐2
160169‐39‐0
29332‐29‐2
217216‐82‐4
17096‐37‐8
59526‐43‐7
1718‐80‐7
217262‐11‐7
92876‐02‐1
1747‐22‐6
8699‐84‐7
009‐14‐9
271‐30‐1
004‐75‐7
5011‐47‐3
50513‐24‐9
224588‐66‐2
32125‐60‐1
160525‐87‐0

Fosfomycin EP Impurity C
23001‐39‐0
114252‐50‐5
Product: FOSINOPRIL IMPURITIES
Fosinopril EP Impurity A/ Fosinopril Related Compound A (Fosinoprilat) 95399‐71‐6
Product: FROVATRIPTAN IMPURITIES
Frovatriptan 3‐Hydrazinylbenzamide Impurity/ Frovatriptan Impurity 5 473927‐51‐4
4‐hydrazinylbenzamide 74885‐67‐9
1,4‐Cyclohexanedione mono(2,2‐dimethyltrimethylene ketal) 69225‐59‐8
Frovatriptan Impurity 6/ 3,3,12,12‐Tetramethyl‐1,5,10,14‐tetraoxadispiro[5.2.5.2]hexadecane 29280‐23‐7
Frovatriptan Impurity 8 / N,N,3,3‐Tetramethyl‐1,5‐dioxaspiro[5.5]undecan‐9‐amine 107431‐14‐1
4‐(Methylamino)cyclohexanone 2,2‐Dimethyltrimethylene Ketal Hydrochloride 158747‐10‐5
Product: FULVESTRANT IMPURITIES
Fulvestrant Int‐TBDMS chain 149051‐24‐1
Fulvestrant Side chain impurity 148757‐89‐5
3‐O‐Methyl Fulvestrant 1221256‐46‐7
Fulvestrant EP Impurity A (7β‐Fulvestrant) 407577‐53‐1
S‐Deoxo Fulvestrant 153004‐31‐0
Product: FUROSEMIDE IMPURITIES
Furosemide EP Impurity A/ Furosemide Related Compound A (Iso Furosemide) 4818‐59‐1
Furosemide EP Impurity B 2736‐23‐4
Furosemide EP Impurity C/ Furosemide Related Compound B (Saluamine) 3086‐91‐7
Furosemide EP Impurity D 5046‐19‐5
Furosemide EP Impurity E 50‐84‐0
Furosemide EP Impurity F (Tetrahydro Furosemide) 4793‐38‐8
Product: FUSIDIC ACID IMPURITIES
Fusidic Acid EP Impurity A (Sodium Fusidate EP Impurity A/ 24,25‐Dihydroxy Fusidic Acid) 80445‐74‐5
Fusidic Acid EP Impurity B (24,25‐Dihydro‐24,25‐Dihydroxy Fusidic Acid‐21,25‐Lactone)
Fusidic Acid EP Impurity C ((24R)‐24,25‐dihydro‐24,25‐Dihydroxy Fusidic Acid 21,24‐Lactone)
Fusidic Acid EP Impurity D ((24S)‐24,25‐Dihydro‐24,25‐Dihydroxy Fusidic Acid 21,24‐Lactone)
Fusidic Acid EP Impurity G (Sodium Fusidate EP Impurity G/ 3‐Didehydro Fusidic Acid/ 3‐Keto Fusidic Acid) 4680‐37‐9

Fusidic Acid EP Impurity H (Sodium Fusidate EP Impurity H/ 11‐Didehydro Fusidic Acid/ 11‐Keto Fusidic Acid) 16711‐91‐4
Fusidic Acid EP Impurity I (Sodium Fusidate EP Impurity I/ 16‐epi‐Deacetyl Fusidic Acid) 5951‐83‐7
Fusidic Acid EP Impurity L (Sodium Fusidate EP Impurity L/ 9,11‐Anhydro Fusidic Acid) 74048‐41‐2
Fusidic Acid EP Impurity O (16‐Deacetyl Fusidic Acid)
13090‐91‐0
55601‐53‐1
Diethanolamine Fusidate 16391‐75‐6
Product: GABAPENTIN IMPURITIES
Gabapentin EP Impurity A/ Gabapentin Related Compound A (Gabapentin Lactam) 64744‐50‐9
Gabapentin EP Impurity B/ Gabapentin Related Compound B 133481‐09‐1
Gabapentin EP Impurity D/ Gabapentin Related Compound D 1076198‐17‐8
Gabapentin EP Impurity E/ Gabapentin Related Compound E (Gabapentin Diacid)
67950‐95‐2
667465‐00‐1
Gabapentin EP Impurity G 1500558‐49‐5
Gabapentin Impurity 1 (α,α’‐Dicyano‐1,1‐cyclohexanediacetamide) 4355‐15‐1
Gabapentin ‐ In house impurity 872696‐79‐2
Gabapentin Diacetic Acid Impurity (1,1‐Cyclohexane diacetic acid) 4355‐11‐7
1,1‐cyclohexane diacetic monoamide 887589‐52‐8
1,1‐Cyclohexanediacetic Anhydride 1010‐26‐0
Gabapentin ‐ In house impurity/ 1,1‐Cyclohexanediacetic Acid Monoamide 99189‐60‐3
Gabapentin desmethylated beta amino acid impurity
1‐[[(2‐Methyl‐1‐oxopropyl)amino]methyl]cyclohexaneacetic Acid 1281568‐83‐9
Gabapentin Di‐Nitrile Impurity 4172‐99‐0
Product: GALANTAMINE IMPURITIES
Galantamine EP Impurity B (Epi‐Galantamine) 1668‐85‐5
Galantamine EP Impurity C (Dihydro Galantamine/ Lycoramine) 21133‐52‐8
Galantamine EP Impurity D (Anhydro Galantamine) 664995‐65‐7
Galantamine EP Impurity E (N‐Desmethyl Galantamine) 41303‐74‐6
Galantamine EP Impurity F (Ent‐Galantamine) 60384‐53‐4
Galantamine O‐Desmethyl Impurity 60755‐80‐8
Galantamine N‐Oxide Impurity 134332‐50‐6

Product: GANCICLOVIR IMPURITIES
Ganciclovir Divalinate Impurity 130914‐71‐5
Product: GATIFLOXACIN IMPURITIES
Gatifloxacin Related Compound A (8‐Hydroxy Gatifloxacin/ O‐Desmethyl Gatifloxacin) 616205‐76‐6
Gatifloxacin Related Compound B/Moxifloxacin Difluoro Hydroxy Acid Impurity 154093‐72‐8
Gatifloxacin Related Compound C (Moxifloxacin Difluoro Methoxy Acid Impurity/ Ciprofloxacin Difluoro 8‐Methoxy
Impurity) 112811‐72‐0
Gatifloxacin Related Compound D (3‐Desmethyl Gatifloxacin) 112811‐57‐1
Gatifloxacin Related Compound E (Iso‐Gatifloxacin/ Gatifloxacin 2‐Methyl Isomer) 1029364‐65‐5
Gatifloxacin N‐Methyl Impurity 114213‐69‐3
Gatifloxacin Despropylene Impurity 172426‐86‐7
Gatifloxacin Desethylene Impurity 172426‐87‐8
Product: GEFITINIB IMPURITIES
4‐(3‐chloropropyl)morpholine 7357‐67‐7
3‐Hydroxy‐4‐methoxybenzonitrile 52805‐46‐6
Gefitinib O‐Desmethyl Impurity 847949‐49‐9
2‐amino‐4‐methoxy‐5‐(3‐morpholinopropoxy)benzonitrile 675126‐27‐9
4‐methoxy‐5‐(3‐morpholinopropoxy)‐2‐nitrobenzonitrile 675126‐26‐8
4‐methoxy‐3‐(3‐morpholinopropoxy)benzonitrile 675126‐28‐0
3‐hydroxy‐4‐methoxybenzonitrile 52805‐46‐6
Gefitinib O‐Desmorpholinopropyl Impurity 184475‐71‐6
Product: GEMCITABINE IMPURITIES
Gemcitabine EP Impurity A (Lamivudine EP Impurity E/ Cytosine) 71‐30‐7
Gemcitabine EP Impurity B (Gemcitabine alpha‐Isomer/ Gemcitabine 1‐Epimer)
95058‐85‐8
122111‐05‐1
3'‐Epi Gemcitabine 3',5'‐Dibenzoate 1268237‐46‐2
5‐O‐Acetyl Gemcitabine
Gemcitabine 3‐Epimer 103882‐85‐5
Product: GLIBENCLAMIDE/ GLYBURIDE IMPURITIES
Glibenclamide EP Impurity A/ Glyburide Related Compound A 16673‐34‐0

Glibenclamide EP Impurity B/ Glyburide Related Compound B 21165‐77‐5
Glibenclamide EP Impurity C 10079‐35‐3
Glibenclamide EP Impurity D 38160‐73‐5
Glibenclamide EP Impurity E 57334‐89‐1
5‐Chloro‐2‐methoxybenzoic Acid 3438‐16‐2
5‐Chloro‐2‐methoxy‐N‐(2‐phenylethyl)benzamide 33924‐49‐1
Product: GLICLAZIDE IMPURITIES
Gliclazide EP Impurity A (Tolbutamide EP Impurity A/ Toluenesulfonamide) 70‐55‐3
Gliclazide EP Impurity C 5577‐13‐9
Gliclazide EP Impurity F (Gliclazide ortho‐Analog) 1076198‐18‐9
Product: GLIMEPIRIDE IMPURITIES
Glimepiride EP Impurity A/ Glimepiride Related Compound A (Glimepiride cis Isomer) 684286‐46‐2
Glimepiride EP Impurity B/ Glimepiride Related Compound B (Glimepiride Sulfonamide) 119018‐29‐0
Glimepiride EP Impurity C/Glimepiride Related Compound C (Glimepiride Ester) 119018‐30‐3
Glimepiride EP Impurity D/ Glimepiride Related Compound D (Glimepiride meta Isomer) 791104‐62‐6
Glimepiride EP Impurity E/ Glimepiride Related Compound E (Glimepiride meta Sulfonamide)
Glimepiride EP Impurity F/ Glimepiride Related Compound F (Glimepiride ortho Ester)
Glimepiride EP Impurity G/ Glimepiride Related Compound G (Glimepiride N‐Methyl Ester)
Glimepiride EP Impurity H/ Glimepiride Related Compound H (Glimepiride Toluene Analog)
Glimepiride EP Impurity I/ Glimepiride Related Compound I (Glimepiride ortho Isomer) 878480‐70‐7
Glimepiride EP Impurity J/ Glimepiride Related Compound J (Glimepiride ortho Isomer) 41176‐98‐1
4‐(2‐Aminoethyl)benzenesulfonamide
35303‐76‐5
6325‐22‐0
Glimepiride Phenylethyl Impurity 247098‐18‐6
Product: GLIPIZIDE IMPURITIES
Glipizide EP Impurity A 33288‐71‐0
Glipizide EP Impurity B (Cyclohexylamine)
108‐91‐8
4998‐76‐9
26227‐54‐3
Glipizide EP Impurity C 13554‐93‐3

Glipizide EP Impurity D 1346600‐54‐1
Glipizide EP Impurity E (5‐Desmethyl‐6‐Methyl Glipizide/ Glipizide 6‐Methyl Analog) 66375‐96‐0
Glipizide EP Impurity F 192118‐08‐4
Glipizide EP Impurity G 33288‐74‐3
Glipizide EP Impurity H 10080‐05‐4
Glipizide EP Impurity I/ Glibenclamide EP Impurity C 10079‐35‐3
4‐(2‐Aminoethyl)benzenesulfonamide
35303‐76‐5
6325‐22‐0
5‐Methyl‐pyrazine‐2‐carboxylic Acid 5521‐55‐1
Product: GLYCEROL IMPURITIES
Ethylene Glycol 107‐21‐1
Product: GLYCOPYRROLATE IMPURITIES
Glycopyrrolate EP Impurity D (Tiaprofenic Acid EP Impurity D/ Metronidazole Benzoate EP Impurity C/ Mefenamic Acid
EP Impurity D) 65‐85‐0
Product: GRISEOFULVIN IMPURITIES
Griseofulvin Dehydro Impurity 3573‐90‐8
Griseofulvic Acid 469‐54‐5
Product: GUAIFENESIN IMPURITIES
Guaifenesin EP Impurity A (Guaiacol/ 2‐Methoxyphenol) 90‐05‐1
Guaifenesin EP Impurity B 14007‐09‐1
Guaifenesin EP Impurity D 16929‐60‐5
Guaifenesin EP Impurity C 1797132‐23‐0
rac Guaifenesin Cyclic Carbonate (Methocarbamol Dioxolone) 2049‐21‐0
Product: HALOPERIDOL IMPURITIES
Haloperidol EP Impurity F 1391052‐67‐7
Haloperidol EP Impurity H (Haloperidol N‐Oxide) 148406‐51‐3
Trans‐Haloperidol N‐Oxide 150214‐93‐0
Haloperidol Decanoate EP Impurity G 52‐86‐8
Product: HYDRALAZINE IMPURITIES
Hydralazine Hydroxy Impurity 119‐39‐1

2,3‐dihy
Hydrala
Phthalol
1‐Chloro
Hydrala
Product
Hydroch
Hydroch
Salamid
Hydroch
5‐Chloro
Benzthia
Product
Hydroco
Hydroco
Hydroco
Hydroco
Hydroco
Hydroco
Hydroco
Hydroco

Hydroco
Hydroco
Product
Hydroco
Hydroco
Hydroco
Hydroco
ydrophthalazine
azine Dimer imp
lactone
ophthalazine
azine Triazolo M
t: HYDROCHLO
hlorothiazide E
hlorothiazide E
de/ Altizide EP I
hlorothiazide E
o Hydrochlorot
azide
t: HYDROCORT
ortisone EP Imp
ortisone EP Imp
ortisone EP Imp
ortisone EP Imp
ortisone EP Imp
ortisone EP Imp
ortisone EP Imp
ortisone EP Imp
ortisone EP Imp
ortisone EP Imp
t: HYDROCORT
ortisone Acetate
ortisone Acetate
ortisone Acetate
ortisone Acetate
e‐1,4‐dione
purity
Methyl Impurity
OROTHIAZIDE
P Impurity A (3
P Impurity B/ H
Impurity A)
P Impurity C (H
thiazide
TISONE IMPUR
purity A (Predn
purity B (cortiso
purity C (Hydro
purity D (6β‐Hy
purity E (6‐Hyd
purity F (Reichs
purity G (Hydro
purity J (Hydroc
purity K (Reichs
purity L (Hydro
TISONE ACETA
e EP Impurity A
e EP Impurity B
e EP Impurity C
e EP Impurity D
y
IMPURITIES
3,4‐Dehydro Hy
Hydrochlorothi
Hydrochlorothia
RITIES
nisolone)
one)
ocortisone Aceta
ydroxycortisol/
drocortisone/ 6
steins Substanc
ocortisone 21‐A
cortisone‐17‐Ac
steins Substanc
ocortisone Aceta
ATE IMPURITIE
A/ Prednisolone
B (Hydrocortiso
C (Prednisolone
D
ydrochlorothiaz
azide Related C
azide Dimer)
ate)
/ 6β‐Hydroxyhy
‐Dehydrocortis
ce S)
Aldehyde)
cetate)
ce S‐21‐Acetate)
ate EP Impurity
ES
e EP Impurity A
one EP Impurity
e EP Impurity C
zide/ Chlorothia
Compound A (B
ydrocortisone)
sol)
)
y B)
A (Hydrocortiso
y L)
/ Methylpredni
azide)
enzothiadiazin
one/Cortisol)
isolone Acetate
e Related Comp
e EP Impurity E)
14
24
87
57
20

58
pound A/
12
40
52
91

50
53
50
53
60
15
14
90
16
64
64

50
64
) 52
50
445‐69‐8
4030‐07‐7
7‐41‐2
784‐45‐2
0062‐41‐3
8‐94‐6
21‐30‐2
02824‐96‐8
233‐42‐1
1‐33‐8
0‐24‐8
3‐06‐5
0‐03‐3
3‐35‐0
00‐99‐7
52‐58‐9
4760‐49‐7
06337‐64‐2
6463‐74‐4
40‐87‐9
41‐77‐0
0‐23‐7
41‐77‐0
2‐21‐1
0‐04‐4

Hydrocortisone Acetate EP Impurity G 81968‐66‐3
Product: HYDROXYCHLOROQUINE IMPURITIES
Hydroxychloroquine EP Impurity B (Hydroxychloroquine O‐Sulfate) 103152‐84‐7
Hydroxychloroquine EP Impurity C (Cletoquine) 4298‐15‐1
Hydroxychloroquine EP Impurity D (Desethyl Chloroquine) 1476‐52‐4
Hydroxychloroquine EP Impurity G (Amodiaquine Dichloro Impurity) 86‐98‐6
O‐Acetylhydroxychloroquine 47493‐14‐1
Product: HYMECROMONE IMPURITIES
Hymecromone EP Impurity B 6320‐42‐9
2,4‐Dihydroxyacetophenone 89‐84‐9
Product: HYOSCINE IMPURITIES
Hyoscine EP Impurity C/ Hyoscyamine EP Impurity A (Ipratropium EP Impurity C/ Ipratropium Bromide Related
Compound C/ DL‐Tropic Acid/ Tropicamide EP Impurity C/ Tropicamide Related Compound C/ Hyoscine Butylbromide
EP Impurity B) 552‐63‐6
Product: HYOSCYAMINE IMPURITIES
Hyoscyamine EP Impurity A (Ipratropium EP Impurity C/ Ipratropium Bromide Related Compound C/ DL‐Tropic Acid/
Hyoscine EP Impurity C/ Tropicamide EP Impurity C/ Tropicamide Related Compound C/ Hyoscine Butylbromide EP
Impurity B) 552‐63‐6
Product: HYROXYZINE IMPURITIES
Hydroxyzine EP Impurity A/ Hydroxyzine Related Compound A (Cetirizine EP Impurity A/ Cetirizine Related Compound
A/ Cetirizine CBHP Impurity) 303-26-4
Hydroxyzine EP Impurity B
3733‐63‐9
13073‐96‐6
Hydroxyzine Impurity 2 (Cetirizine EP Impurity D/ Cetirizine Dimer Impurity)
346451‐15‐8
856841‐95‐7
Hydroxyzine Acetic Acid (Cetirizine EP Impurity E)
682323‐77‐9
83881‐56‐5
Product: IBRUTINIB IMPURITIES
4‐phenoxybenzohydrazide 143667‐36‐1
Product: IBUPROFEN IMPURITIES
Ibuprofen EP Impurity A (m‐Isobutyl Ibuprofen) 66622‐47‐7

Ibuprofen EP Impurity B 3585‐49‐7
Ibuprofen EP Impurity C 59512‐17‐3
Ibuprofen EP Impurity D 938‐94‐3
Ibuprofen EP Impurity E/ Ibuprofen Related Compound C 38861‐78‐8
Ibuprofen EP Impurity F 65322‐85‐2
Ibuprofen EP Impurity J/ Ibuprofen Related Compound J (1‐Oxo Ibuprofen) 65813‐55‐0
Ibuprofen EP Impurity L 53949‐53‐4
Ibuprofen EP Impurity N (p‐Ethylhydratropic Acid) 3585‐52‐2
Ibuprofen EP Impurity P (Ibuprofen Alcohol) 36039‐36‐8
2‐(4‐(2‐Methylprop‐1‐enyl)phenyl)propanoic acid 75625‐99‐9
(+) Ibuprofen
(‐) Ibuprofen
Ibuprofen Propyl Analogue 3585‐47‐5
Product: IFOSFAMIDE IMPURITIES
Ifosfamide EP Impurity C 870‐24‐6
Product: ILOPERIDONE IMPURITIES
(S)‐Hydroxy Iloperidone 501373‐88‐2
(R)‐Hydroxy Iloperidone 501373‐87‐1
Iloperidone Dimer Impurity 1375651‐23‐2
Iloperidone Desfluoro Impurity 133454‐46‐3
Iloperidone Hydroxypropoxy Impurity 207298‐39‐3
Acetyl guaiacol 204781‐71‐5
2'‐Hydroxy‐3'‐methoxyacetophenone 703‐98‐0
3‐(4‐Piperidinyl)‐1,2‐benzisoxazole Hydrochloride 84163‐22‐4
1,1'‐((propane‐1,3‐diylbis(oxy))bis(3‐methoxy‐4,1‐phenylene))bis(ethan‐1‐one) 19417‐90‐4
4′‐Hydroxy‐3′‐methoxyacetophenone 498‐02‐2
Product: IMATINIB IMPURITIES
Imatinib EP Impurity A (Imatinib Dimethylamino Impurity) 55314‐16‐4
Imatinib EP Impurity B (Imatinib Guanidino Impurity)
581076‐65‐5
581076‐67‐7

Imatinib EP Impurity C (Imatinib N‐Desmethyl Impurity) 404844‐02‐6
Imatinib EP Impurity D (Imatinib Dimer) 1821122‐73‐9
Imatinib EP Impurity F (Imatinib Diamine Impurity) 152460‐10‐1
Imatinib EP Impurity G (Cyclizine impurity A/ Cyclizine Related Compound A/ 1‐Methylpiperazine)
109‐01‐3
34352‐59‐5
Imatinib EP Impurity H 350‐03‐8
Imatinib EP Impurity I (Metformin EP Impurity F/ Dacarbazine EP Impurity D) 506‐59‐2
Imatinib EP Impurity J (Imatinib Piperazine‐N1‐Oxide) 571186‐91‐9
Imatinib Impurity B 404844‐11‐7
Imatinib Bis Impurity 1365802‐18‐1
Imatinib Carboxylic Impurity 106261‐49‐8
N‐Desmethyl Imatinib
404844‐02‐3
404844‐03‐7
4‐(1‐piperazinylmethyl)benzoic Acid
220213‐15‐0
86620‐70‐4
Ethyl Methane Sulfonate 62‐50‐0
Methyl Methane Sulfonate 66‐27‐3
Methanesulfonic Acid Hexyl Ester 16156‐50‐6
Isopropyl Methane Sulfonate 926‐06‐7
Product: IMIPRAMINE IMPURITIES
Imipramine EP Impurity A (Desipramine HCl)
58‐28‐6
50‐47‐5
5H‐Dibenz[b,f]azepine‐5‐propanamine 303‐54‐8
Product: INDAPAMIDE IMPURITIES
Indapamide EP Impurity C 102789‐79‐7
Triethylamine sulfate 54272‐29‐6
4‐chloro‐3‐sulfamoylbenzoic acid 1205‐30‐7
Product: INDOMETHACIN IMPURITIES
Indomethacin EP Impurity A/ Indomethacin Related Compound B (Acemetacin EP Impurity A/ Bezafibrate EP Impurity B) 74‐11‐3
Indomethacin EP Impurity B/ Indomethacin Related Compound A (Indomethacin N‐Deschlorobenzoyl Impurity) 2882‐15‐7

Indomethacin EP Impurity C 4018‐82‐0
Indomethacin EP Impurity F 402849‐27‐8
Indomethacin EP Impurity J 402849‐25‐6
Product: INTEDANIB IMPURITIES
4‐Chloro‐3‐nitrobenzoic acid 96‐99‐1
Product: IPRATROPIUM BROMIDE IMPURITIES
Ipratropium EP Impurity C/ Ipratropium Bromide Related Compound C (DL‐Tropic Acid/ Hyoscine EP Impurity C/
Hyoscyamine EP Impurity A/ Tropicamide EP Impurity C/ Tropicamide Related Compound C/ Hyoscine Butylbromide EP
Impurity B) 552‐63‐6
Ipratropium Bromide EP Impurity F 17812‐46‐3
Product: IRBESARTAN IMPURITIES
Irbesartan EP Impurity A/ Irbesartan Related Compound A 748812‐53‐5
Irbesartan EP Impurity E (Irbesartan Methyl Impurity/ Losartan EP Impurity E/ Candesartan Methyl Impurity/ Losartan
Methyl Impurity) 120568‐11‐8
Irbesartan Lactam Impurity 151257‐01‐1
Irbesartan Bromo Nitrile Impurity 114772‐54‐2
Irbesartan Cyano Impurity 138401‐24‐8
Irbesartan Dibromomethyl Impurity (Losartan Dibromomethyl Impurity/ Valsartan Dibromomethyl Impurity) 209911‐63‐7
Irbesartan Triphenylmethanol Impurity (Losartan EP Impurity G/ Triphenylmethanol/ Trityl Alcohol/ Candesartan Trityl
Alcohol Impurity/ Zidovudine EP Impurity D) 76‐84‐6
Irbesartan Dibromomethyl Impurity (2’‐Cyano‐4‐(dibromomethyl)biphenyl) 209911‐63‐7
Irbesartan Hydroxy Impurity (Candesartan Hydroxy Impurity/ Losartan Hydroxy Impurity/ Losartan EP Impurity B) 160514‐13‐6
Irbesartan Dibromo N2‐Trityl Impurity (Candesartan Dibromo N2‐Trityl Impurity/ Candesartan Dibromo TTBB Impurity/
Losartan Dibromo N2‐Trityl Impurity/ Olmesartan Dibromo N2‐Trityl Impurity/ Valsartan Dibromo N2‐Trityl Impurity) 151052‐34‐5
Irbesartan Dimer Impurity 1346598‐52‐4
Demethyl Irbesartan 158778‐58‐6
2‐[4‐(aminomethyl)phenyl]benzonitrile 133690‐92‐3
Product: IRINOTECAN IMPURITIES

Irinotecan EP Impurity E/ Irinotecan Related Compound B (7‐Ethyl‐10‐Hydroxy Camptothecin/ 11‐Ethyl‐9‐Hydroxy
Camptothecin) 86639‐52‐3
Irinotecan EP Impurity G/ Irinotecan Related Compound G (7,11‐Diethyl‐10‐hydroxycamptothecin/ 8,11‐Diethyl‐9‐
Hydroxy Camptothecin) 947687‐01‐6
Product: ISOCONAZOLE IMPURITIES
Isoconazole EP Impurity B (Tioconazole EP Impurity D/ Fenticonazole EP Impurity A/ Econazole EP Impurity A/
Econazole Related Compound A/ Miconazole EP Impurity A/ Deschlorobenzyl Econazole/ Isoconazole Nitrate EP
Impurity A) 24155‐42‐8
Product: ISOCONAZOLE NITRATE IMPURITIES
Isoconazole Nitrate EP Impurity A (Isoconazole EP Impurity B/ Tioconazole EP Impurity D/ Fenticonazole EP Impurity A/
Econazole EP Impurity A/ Econazole Related Compound A/ Miconazole EP Impurity A/ Deschlorobenzyl Econazole) 24155‐42‐8
Product: ISONIAZID IMPURITIES
Isoniazid dimer (1,2‐Diisonicotinoylhydrazine) 4329‐75‐3
2‐Isoniazid 1452‐63‐7
Product: ITRACONAZOLE IMPURITIES
Itraconazole EP Impurity A (Itraconazole 4‐Methoxy Derivative) 252964‐68‐4
Itraconazole EP Impurity B 854372‐77‐3
Itraconazole EP Impurity C (Propyl Itraconazole) 74855‐91‐7
Itraconazole EP Impurity D (Isopropyl Itraconazole) 89848‐49‐7
Itraconazole EP Impurity E (trans‐Itraconazole) 252964‐65‐1
Itraconazole EP Impurity F (Butyl Itraconazole) 89848‐51‐1
Itraconazole EP Impurity G
1‐(4‐Methyloxy‐phenyl)‐4‐(4‐nitro‐phenyl)‐piperazine 74852‐61‐2
Product: IVABRADINE IMPURITIES
Ivabradine N‐Oxide
N‐Desmethyl Ivabradine 1246638‐08‐3
Ivabradine Dehydro Impurity 1086026‐31‐4
Hydroxy Ivabradine 1235547‐07‐5
7,8‐Dimethoxy‐1,3‐dihydro‐2H‐3‐benzazepin‐2‐one 73942‐87‐7
3‐(3‐Chloropropyl)‐1,3,4,5‐tetrahydro‐7,8‐dimethoxy‐2H‐3‐benzazepin‐2‐one 85175‐65‐1
Ivabradine HCl R‐Isomer 148849‐68‐7

Product: IVACAFTOR IMPURITIES
Ivacaftor Carboxylic Acid Impurity 1246213‐24‐0
Ivacaftor Hydroxymethyl Impurity 1246213‐23‐9
Product: IVERMECTIN IMPURITIES
Ivermectin EP Impurity A (Avermectin B1a) 65195‐55‐3
Ivermectin EP Impurity D 102190‐55‐6
Product: KETOCONAZOLE IMPURITIES
Ketoconazole EP Impurity C (Ketoconazole 4‐Epimer) 83374‐59‐8
Ketoconazole EP Impurity E 134071‐44‐6
1‐Acetyl‐4‐(4‐hydroxyphenyl)piperazine 67914‐60‐7
Product: KETOPROFEN IMPURITIES
Ketoprofen EP Impurity A/ Ketoprofen Related Compund D 66067‐44‐5
Ketoprofen EP Impurity B (Desmethyl Ketoprofen) 22071‐22‐3
Ketoprofen EP Impurity C/ Ketoprofen Related Compund C 68432‐95‐1
Ketoprofen EP Impurity D/ Ketoprofen Related Compund A 107257‐20‐5
Ketoprofen EP Impurity E (Ketoprofen Amide) 59512‐16‐2
Ketoprofen EP Impurity F/ Ketoprofen Related Compund F 42872‐30‐0
Ketoprofen EP Impurity G 5537‐71‐3
N‐Boc‐glycine 4530‐20‐5
Product: KETOROLAC IMPURITIES
Ketorolac EP Impurity A/ Ketorolac Related Compound B (1‐Hydroxy Ketorolac) 154476‐25‐2
Ketorolac EP Impurity B/ Ketorolac Related Compound C (1‐Keto Ketorolac) 113502‐52‐6
Ketorolac EP Impurity C (6‐Benzoyl Ketorolac) 1026936‐07‐1
Ketorolac EP Impurity D (1‐Methoxy Ketorolac) 1391053‐45‐4
Ketorolac EP Impurity E/ Ketorolac Related Compound A (Ketorolac Tris Amide) 167105‐80‐8
Ketorolac EP Impurity G (1‐Hydroxy Ketorolac Methyl Ester) 1391051‐90‐3
Ketorolac EP Impurity H (Ketorolac Methyl Ester) 80965‐09‐9
Ketorolac EP Impurity I/ Ketorolac Related Compound D (1‐Decarboxy Ketorolac) 113502‐55‐9
Ketorolac EP Impurity J (Ketorolac Ethyl Ester) 108061‐03‐6
Ketorolac Trometamol/ Ketorolac Tromethamine 74103‐07‐4

Ketorolac 4‐Hydroxy Metabolite 111930‐01‐9
Ketorolac Bromo Impurity 328936‐18‐1
Ketorolac Acid 74103‐06‐3
Product: KETOTIFEN IMPURITIES
Ketotifen EP Impurity A 4673‐38‐5
Ketotifen EP Impurity G (9,10‐Dioxo Ketotifen) 43076‐16‐0
Product: LABETALOL IMPURITIES
Labetalol EP Impurity A (Labetalol 1‐Carboxylic Acid) 1391051‐99‐2
Labetalol EP Impurity B (Labetalol 1‐Carboxylic Acid Methyl Ester)
802620‐01‐5
33778‐93‐7
Labetalol EP Impurity C
Labetalol EP Impurity D 32780‐65‐7
Labetalol EP Impurity E (Labetalol Piperadine Dimer)
Labetalol EP Impurity F
127988‐63‐0
96441‐14‐4
Labetalol EP Impurity G
5‐(2‐(diphenethylamino)acetyl)‐2‐hydroxybenzamide 30566‐92‐8
Labetalol Acetonide Impurity
5‐Acetyl‐2‐(phenylmethoxy)benzamide 75637‐30‐8
3‐Amino‐1‐(4‐hydroxyphenyl)butane 52846‐75‐0
Product: LACIDIPINE IMPURITIES
Lacidipine EP Impurity A (Lacidipine Ethyl Methyl Diester) 103890‐81‐9
Lacidipine EP Impurity B (Dehydro Lacidipine) 130996‐24‐6
2‐Formylbenzoic Acid 119‐67‐5
2‐Vinyl benzaldehyde 28272‐96‐0
Product: LACOSAMIDE IMPURITIES
Lacosamide EP Impurity A (Lacosamide (S)‐Isomer) 175481‐37‐5
Lacosamide EP Impurity B (Lacosamide O‐Acetyl Impurity) 1318777‐54‐6
Lacosamide EP Impurity D (Lacosamide N‐Desacetyl Impurity) 196601‐69‐1
Lacosamide EP Impurity E (Lacosamide N‐Desacetyl O‐Desmethyl Impurity) 175481‐39‐7

Lacosamide EP Impurity F (Lacosamide O‐Desmethyl Impurity) 175481‐38‐6
Lacosamide EP Impurity G (N‐Benzylacetamide) 588‐46‐5
Lacosamide EP Impurity I ((S)‐N‐benzyl‐2‐(3‐benzylureido)‐3‐methoxypropanamide)
Lacosamide EP Impurity J (Phenylmethanamine) 100‐46‐9
Lacosamide Impurity K 86921‐49‐5
Lacosamide Related Compound F 171623‐02‐2
N‐Methyl Lacosamide 388619‐64‐5
N‐acetyl O‐methyl L‐serine methyl ester
1,3‐Dibenzyl‐urea 1466‐67‐7
(R)‐2‐(Acetylamino)‐3‐methoxypropionic Acid 196601‐67‐9
Lacosamide N‐Ethylcarbonyl Analog 1318777‐56‐8
Product: LAMIVUDINE IMPURITIES
Lamivudine EP Impurity A (Lamivudine Acid) 173829‐09‐9
Lamivudine EP Impurity C (Acetylsalicylic Acid EP Impurity C/ Salicylic Acid/ Mesalazine EP Impurity H/ Sulfasalazine EP
Impurity H) 69‐72‐7
Lamivudine EP Impurity D (ent‐Lamivudine) 134680‐32‐3
Lamivudine EP Impurity E (Cytosine/ Gemcitabine EP Impurity A) 71‐30‐7
Lamivudine EP Impurity F (Fluorouracil EP Impurity C/ Uracil) 66‐22‐8
Lamivudine EP Impurity G (Lamivudine (3S)‐Sulfoxide) 160552‐55‐6
Lamivudine EP Impurity H (Lamivudine (3R)‐Sulfoxide) 160552‐54‐5
Lamivudine EP Impurity J (Lamivudine Dione Impurity) 145986‐07‐8
Lamivudine 5‐Epimer 139757‐68‐9
Lamivudine 2‐Epimer 136846‐20‐3
Product: LAMOTRIGINE IMPURITIES
Lamotrigine EP Impurity A/ Lamotrigine Related Compound C 252186‐78‐0
Lamotrigine EP Impurity B & Lamotrigine EP Impurity C Mixture
94213‐24‐8
94213‐23‐7
84689‐20‐3
Lamotrigine EP Impurity D 661463‐79‐2

Lamotrigine EP Impurity E/ Lamotrigine Related Compound B 50‐45‐3
Lamotrigine EP Impurity F/ Lamotrigine Related Compound D 252186‐79‐1
Lamotrigine EP Impurity G 38943‐76‐9
2,3‐dichloro benzoyl cyanide 77668‐42‐9
2,3‐Dichloro benzoyl chloride 2905‐60‐4
Hydroxyamino Lamotrigine/ Lamotrigine Hydroxyl Amine
Lamotrigine N2‐Oxide 136565‐76‐9
Lamotrigine 3,3 Dimer Impurity 1797983‐48‐2
2,3‐Dichlorobenzoic Acid Anhydride 252186‐80‐4
2,4‐Dichlorobenzoyl Chloride 89‐75‐8
2,3‐Dichlorobenzoic Anhydride 51417‐52‐8
2,4 Dichlorobenzoyl Nitrile 35022‐43‐6
2,5 Dichlorobenzoyl nitrile 64985‐85‐9
Product: LANSOPRAZOLE IMPURITIES
Lansoprazole EP Impurity A (Lansoprazole N‐Oxide) 213476‐12‐1
Lansoprazole EP Impurity B/ Lansoprazole Related Compound A (Lansoprazole Sulfone) 131926‐99‐3
Lansoprazole EP Impurity C/ Lansoprazole Related Compound B (Lansoprazole Sulfide) 103577‐40‐8
Lansoprazole EP Impurity D (Rabeprazole EP Impurity K) 615‐16‐7
Lansoprazole EP Impurity E (Rabeprazole Related Compound C) 583‐39‐1
Lansoprazole EP Impurity F (Rabeprazole EP Impurity H/Rabeprazole Related Compound F/ Rabeprazole 4‐Chloro
Analog) 168167‐42‐8
Lansoprazole EP Impurity F Sulfide (4‐Desmethoxypropoxyl‐4‐Chloro Rabeprazole Sulfide/ Lansoprazole Sulfide 4‐Chloro
Analog) 103312‐62‐5
Lansoprazole Sulphone N‐Oxide 953787‐54‐7
Lansoprazole Sulfide N‐Oxide 163119‐30‐0
Lansoprazole S‐Isomer/ Levolansoprazole 138530‐95‐7
Lansoprazole Chloromethyl Impurity 127337‐60‐4

4‐chloro‐2‐(chloromethyl)‐3‐methylpyridine hydrochloride 152402‐97‐6
Lansoprazole 4‐Nitro Analog 142384‐07‐4
Lansoprazole 5‐Hydroxy Impurity
131926‐98‐2
1329613‐29‐7
Lansoprazole Hydroxymethyl Impurity 103577‐66‐8
Lansoprazole Nitro Impurity 37699‐43‐7
Lansoprazole R‐Isomer 138530‐94‐6
Lansoprazole Sulfide 4‐Hydroxy Analog 131926‐97‐1
Lansoprazole Thioxo Impurity 1246819‐06‐6
Product: LANTHNUM CARBONATE IMPURITIES
Lanthanum hydroxyl carbonate Form‐I
Lanthanum hydroxyl carbonate Form‐II
Product: LATANOPROST IMPURITIES
Latanoprost Related Compound A (5,6‐trans‐Latanoprost) 913258‐34‐1
15‐Keto Latanoprost 135646‐98‐9
Latanoprost‐ Acid 41639‐83‐2
15‐epi Latanoprost 145773‐22‐4
5‐(Diphenylphosphoryl)pentanoic acid 71140‐70‐0
Methyl 5‐(diphenylphosphoryl)pentanoate 146964‐27‐4
15‐Keto Latanoprost Acid 369585‐22‐8
Product: LEFLUNOMIDE IMPURITIES
Leflunomide EP Impurity A/ Leflunomide Related Compound A 455‐14‐1
Leflunomide EP Impurity B/ Leflunomide Related Compound B 163451‐81‐8
Leflunomide EP Impurity C (Leflunomide‐3‐isomer) 61643‐23‐0
Leflunomide EP Impurity D (5‐Methylisoxazole‐4‐carboxylic Acid) 42831‐50‐5
Leflunomide EP Impurity E (5‐Desmethyl‐3‐methyl Leflunomide) 208401‐20‐1
Leflunomide EP Impurity F (Leflunomide‐2‐isomer) 1403564‐06‐6
Leflunomide EP Impurity G (5‐methyl‐N‐(p‐tolyl)isoxazole‐4‐carboxamide) 724429‐16‐7
Leflunomide EP Impurity H (2‐Cyano‐N‐[4‐(trifluoromethyl)phenyl]acetamide) 24522‐30‐3
Leflunomide Impurity (Ethyl 5‐methylis/ 5‐METHYL‐4‐ISOXAZOLECARBOXYLATE) 51135‐73‐0

3‐Methylisoxazole‐4‐carboxylic Acid 17153‐20‐7
3‐Aminobenzotrifluoride 98‐16‐8
2‐Aminobenzotrifluoride 88‐17‐5
Cyanoacetic Acid 372‐09‐8
Product: LENALIDOMIDE IMPURITIES
Methyl 2‐(chloromethyl)‐3‐nitrobenzoate 1218910‐61‐2
Lenalidomide 4‐Nitro Impurity 827026‐45‐9
5‐amino‐2‐(4‐amino‐1‐oxoisoindolin‐2‐yl)‐5‐oxopentanoic acid 2197420‐75‐8
tert‐Butyl (2,6‐Dioxopiperidin‐3‐yl)carbamate 31140‐42‐8
3‐Amino‐piperidine‐2,6‐dione
2686‐86‐4
2353‐44‐8
2‐(4‐amino‐1‐oxoisoindolin‐2‐yl)pentanedioic acid 295357‐66‐3
5‐amino‐4‐(4‐amino‐1‐oxoisoindolin‐2‐yl)‐5‐oxopentanoic acid 874760‐69‐7
2‐(Bromomethyl)‐3‐nitrobenzoic Acid Methyl Ester 98475‐07‐1
2‐(4‐Amino‐1‐oxoisoindolin‐2‐yl)pentanediamide 2197414‐55‐2
dimethyl 2‐(4‐amino‐1‐oxoisoindolin‐2‐yl)pentanedioate 1198299‐50‐1
methyl 5‐amino‐2‐(4‐amino‐1‐oxoisoindolin‐2‐yl)‐5‐oxopentanoate 1240215‐87‐5
methyl 5‐amino‐4‐(4‐amino‐1‐oxoisoindolin‐2‐yl)‐5‐oxopentanoate 1198299‐53‐4
Methyl 2‐Methyl‐4‐nitrobenzoate 62621‐09‐4
Methyl 2‐(Bromomethyl)‐4‐nitrobenzoate 133446‐99‐8
Methyl 2‐(Bromomethyl)‐5‐nitrobenzoate 90725‐68‐1
2‐Bromomethyl‐6‐nitrobenzoic Acid Methyl Ester 61940‐21‐4
Product: LERCANIDIPINE IMPURITIES
Lercanidipine Impurity D/ Dehydro Lercanidipine 887769‐34‐8
Lercanidipine Dimethyl Ester Impurity (Nitrendipine EP Impurity B/ Nicardipine Related Compound C/ Nicardipine
Dimethyl Ester Analog/ m‐Nifedipine) 21881‐77‐6
1,4‐Dihydro‐2,6‐dimethyl‐4‐(3‐nitrophenyl)‐3,5‐pyridinedicarboxylic acid 1‐methylpropyl ester 74936‐74‐6
N‐Methyl‐3,3‐diphenylpropylamine 28075‐29‐8
1‐Chloro‐2‐methyl‐2‐propanol 558‐42‐9
Lercanidipine Acid 1119226‐97‐9

Product: LETROZOLE IMPURITIES
Letrozole EP Impurity A/ Letrozole Related Compound A (Iso Letrozole) 112809‐52‐6
Letrozole EP Impurity B 113402‐31‐6
Letrozole 4‐Descyano 4‐Bromo Impurity 143030‐54‐0
4,4'‐Methylenedibenzonitrile 10466‐37‐2
Product: LEVALBUTEROL IMPURITIES
Levalbuterol Related Compound B (Salbutamol EP Impurity C/ 2‐Deshydroxy Salbutamol/ Albuterol Related Compound
A) 18910‐68‐4
Levalbuterol Related Compound D (Salbutamol EP Impurity D/ Salbutamol Aldehyde Impurity) 156339‐88‐7
Levalbuterol Related Compound E 69716‐64‐9
Levalbuterol Related Compound H (Salbutamol EP Impurity A/ Salbutamol Methyl Ether) 870076‐72‐5
Product: LEVAMISOLE IMPURITIES
Levamisole EP Impurity D 4335‐28‐8
Product: LEVETIRACETAM IMPURITIES
Levetiracetam EP Impurity A (Levetiracetam Carboxylic Acid Racemate) 67118‐31‐4
Levetiracetam EP Impurity B 358629‐47‐7
Levetiracetam EP Impurity C
72762‐00‐6
142‐08‐5
Levetiracetam EP Impurity D (Levetiracetam R‐Isomer) 103765‐01‐1
Levetiracetam EP Impurity E/ (R)‐(+)‐Phenyl ethyl amine 3886‐69‐9
Levitiracetam Related compound A 102767‐31‐7
Levitiracetam Related compound B 7682‐20‐4
Levetiracetam Impurity 3 (Piracetam EP Impurity A/ Povidone EP Impurity B/ pyrrolidin‐2‐one/2‐Oxo‐4‐butyrolactam) 616‐45‐5
Levetiracetam Racemate (Etiracetam) 33996‐58‐6
Levetiracetam Acid 103833‐72‐3
Levetiracetam Carboxylic Acid 102849‐49‐0
(S)‐(‐)‐1‐Phenylethylamine 2627‐86‐3
Product: LEVOCETRIZINE IMPURITIES
4‐Chlorobenzhydryl Chloride 134‐83‐8

Levocetirizine Amide 909779‐33‐5
Levocetirizine Ethyl Ester 1116338‐10‐3
Product: LEVODOPA IMPURITIES
Levodopa EP Impurity A/ Levodopa Related Compound A (2‐Hydroxy Levodopa) 27244‐64‐0
Levodopa EP Impurity B (L‐Tyrosine) 60‐18‐4
Levodopa EP Impurity C/ Levodopa Related Compound B (3‐Methyl‐DL‐Dopa/ 3‐Methoxy‐DL‐tyrosine) 7636‐26‐2
Levodopa EP Impurity D (D‐Dopa) 5796‐17‐8
L‐Veratrylglycine (DMPA) 32161‐30‐1
Product: LEVODROPROPIZINE IMPURITIES
Levodropropizine EP Impurity A (Dextrodropropizine/ Dropropizine R‐Isomer) 99291‐24‐4
Levodropropizine EP Impurity B 92‐54‐6
Levodropropizine EP Impurity C (Glycidol) 556‐52‐5
Product: LEVOFLOXACIN IMPURITIES
Levofloxacin EP Impurity B/ Levofloxacin Related Compound A (N‐Desmethyl Levofloxacin) 117707‐40‐1
Levofloxacin EP Impurity C (Levofloxacin N‐oxide/ Oxifloxacin EP Impurity F)
117678‐38‐3
117678‐37‐2
Levofloxacin EP Impurity D/ Levofloxacin Related Compound F (Levofloxacin Desfluoro Impurity) 117620‐85‐6
Levofloxacin EP Impurity E (Levofloxacin Descarboxy Impurity) 178964‐53‐9
Levofloxacin EP Impurity F/ Levofloxacin Related Compound B (Levofloxacin Difluoro Carboxylic Acid) 100986‐89‐8
Levofloxacin EP Impurity G/ Levofloxacin Related Compound E (Levofloxacin Desethylene Impurity) 1346603‐62‐0
Levofloxacin EP Impurity H/ Levofloxacin Related Compound C (Levofloxacin Ethyl Ester) 177472‐30‐9
Levofloxacin EP Impurity I (Levofloxacin 9‐Piperazinyl Isomer) 178912‐62‐4
Ofloxacin ‐ Racemic mixture 82419‐36‐1
Ofloxacin R‐Isomer 100986‐86‐5
Desmethyl Ofloxacin (Ofloxacin EP Impurity E) 82419‐52‐1
Levofloxacin Diamine Impurity (N,N‐Didesethylene Levofloxacin)
1797510‐34‐9
1797099‐76‐3
2,3,4‐Trifluoro‐α‐[[[(1S)‐2‐hydroxy‐1‐methylethyl]amino]methylene]‐β‐oxo‐benzenepropanoic Acid Ethyl Ester 601490‐35‐1
N,N’‐Desethylene Levofloxacin Hydrochloride 151250‐76‐9

Product: LEVONORGESTREL IMPURITIES
Tetralone 1078‐19‐9
Product: LEVOSULPIRIDE IMPURITIES
(2S)‐2‐Aminomethyl‐1‐ethylpyrrolidine 22795‐99‐9
Product: LEVOTHYROXINE IMPURITIES
Levothyroxine EP Impurity B 1628720‐66‐0
Levothyroxine EP Impurity C/ Levothyroxine T3‐Acetic Acid (Liothyronine EP Impurity C/ Triiodothyroacetic Acid) 51‐24‐1
Levothyroxine EP Impurity D/ T4‐Acetic Acid (Liothyronine EP Impurity D/ Tetraiodothyroacetic Acid) 67‐30‐1
Levothyroxine EP Impurity E (Liothyronine EP Impurity E/ Diiodothyronine/ 3,5‐Diiodo‐L‐thyronine) 1041‐01‐6
Levothyroxine EP Impurity F (Levothyroxine T6 Impurity) 911661‐90‐0
Levothyroxine EP Impurity H (Levothyroxine Benzoic Acid Impurity) 2055‐97‐2
Levothyroxine EP Impurity I 2016‐06‐0
Levothyroxine EP Impurity J 4604‐41‐5
Levothyroxine EP Impurity K 5817‐39‐0
Levothyroxine T4‐Acetamide Impurity 176258‐88‐1
Levothyroxine beta‐Hydroxy Impurity 107849‐54‐7
Levothyroxine D‐Isomer 51‐49‐0
Levothyroxine Ethyl Ester 76353‐71‐4
Levothyroxine Hydroxyphenoxy Aldehyde Impurity (3,5‐Diiodo Thyroaldehyde) 828‐49‐1
Levothyroxine Methyl Ester 32180‐11‐3
Levothyroxine N‐Acetyl Impurity 26041‐51‐0
Levothyroxine N‐Formyl Impurity 671235‐41‐9
Levothyroxine T4‐Hydroxyacetic Acid 93647‐48‐4
L‐Thyronine/ Desiodothyroxine 1596‐67‐4
Levothyroxine In house Impurity 5563‐89‐3
Product: LICARBAZEPINE IMPURITIES
Licarbazepine R‐Isomer 104746‐03‐4
Licarbazepine Acetate R‐Isomer 186694‐45‐1
Product: LIDOCAINE IMPURITIES

Lidocaine EP Impurity A/ Lidocaine Related Compound A (Bupivacaine EP Impurity F/ Ropivacaine EP Impurity H/
Ropivacaine Related Compound A/ Mepivacaine EP Impurity A)
87‐62‐7
21436‐98‐6
Lidocaine EP Impurity B (Lidocaine N‐Oxide) 2903‐45‐9
Lidocaine EP Impurity C 2198‐53‐0
Lidocaine EP Impurity D (N‐Desethyl Lidocaine/ Nor Lidocaine)
7728‐40‐7
7729‐94‐4
Lidocaine EP Impurity E/ Lidocaine Related Compound E (Lidocaine Dimer Impurity)
745798‐07‐6
1135231‐62‐7
Lidocaine EP Impurity F (Lidocaine 2,3‐Dimethyl Analog) 857170‐72‐0
Lidocaine EP Impurity G
42459‐30‐3
35891‐87‐3
Lidocaine EP Impurity H 1131‐01‐7
Lidocaine EP Impurity I (Lidocaine 2,4‐Dimethyl Analog)
17289‐53‐1
17289‐54‐2
Lidocaine EP Impurity J (Lidocaine 2,5‐Dimethyl Analog) 1012864‐23‐1
Lidocaine EP Impurity K (N‐Desethyl‐N‐Methyl Lidocaine)
74634‐66‐5
50295‐20‐0
Glycinexylidide/ 2‐Amino‐N‐(2,6‐dimethylphenyl)acetamide
18865‐38‐8
35891‐83‐9
Product: LINAGLIPTIN IMPURITIES
Linagliptin Impurity 8 (Linagliptin N‐Formyl Impurity)
Linagliptin Impurity 10 (S‐Isomer) 668270‐11‐9
Linagliptin N‐Acetyl Impurity/ Linagliptin acetamide 1803079‐49‐3
Linagliptin impurity 16 1911621‐52‐7
Linagliptin Related Compound B (N‐Boc Linagliptin) 668273‐75‐4
Linagliptin 2‐Chloromethyl Impurity 109113‐72‐6
1‐[(4‐Methylquinazolin‐2‐yl)methyl]‐3‐methyl‐7‐(2‐butyn‐1‐yl)‐8‐bromoxanthine 853029‐57‐9
Linagliptin Impurity S 1638744‐06‐5
(S)‐piperidin‐3‐amine dihydrochloride 334618‐07‐4

Linagliptin 8‐Bromo Impurity 93703‐24‐3
Linagliptin 3‐Methyl Xanthine Impurity (Pentoxifylline EP Impurity B/ Theophylline EP Impurity B) 1076‐22‐8
Linagliptin Glucose adduct
Linagliptin‐HBr adduct
Linagliptin Dimer
Des‐Bromolinagliptin
7‐benzyl‐8‐bromo‐3‐methyl‐1H‐purine‐2,6(3H,7H)‐dione 93703‐26‐5
8‐Bromo‐7‐(but‐2‐yn‐1‐yl)‐3‐methyl‐1Hpurin‐2,6(3H,7H)‐dione 666816‐98‐4
7‐(but‐2‐yn‐1‐yl)‐3‐methyl‐1H‐purine‐2,6(3H,7H)‐dione 586408‐08‐4
(4‐methylquinazolin‐2‐yl)methanol 13535‐91‐6
7‐benzyl‐3‐methyl‐1H‐purine‐2,6(3H,7H)‐dione 56025‐86‐6
7‐(but‐2‐yn‐1‐yl)‐8‐(dimethylamino)‐3‐methyl‐1‐((4‐methylquinazolin‐2‐yl)methyl)‐1H‐purine‐2,6(3H,7H)‐dione 1646355‐34‐1
Linagliptin Regio‐isomer 1446263‐38‐2
N‐Phthalimidelinagliptin 886588‐63‐2
(R)‐3‐Amino‐1‐benzylpiperidine 168466‐84‐0
Product: LINCOMYCIN IMPURITIES
Lincomycin EP Impurity C (N‐Desmethyl Lincomycin)
2256‐16‐8
14600‐41‐0
Lincomycin EP Impurity B 37744‐65‐3
Product: LINEZOLID IMPURITIES
Linezolid Related Compund A (Linezolid Desacetamide Azide) 168828‐84‐0
Linezolid Related Compund B (ThioLinezolid) 216868‐57‐4
Linezolid Related Compund C (Linezolid Desacetyl Analog) 168828‐90‐8
Linezolid Related Compound D (Linezolid Mesylate Impurity) 174649‐09‐3
Linezolid Benzyl Impurity 168828‐81‐7
Linezolid Amine Impurity 93246‐53‐8
Linezolid Intermediate Impurity‐3 2689‐39‐6
Linezolid Desfluoro Impurity 556801‐15‐1
Linezolid R‐Isomer 872992‐20‐6

Linezolid Dimer 908143‐04‐4
Linezolid N‐Oxide 189038‐36‐6
Linezolid Hydroxymethyl Impurity (Linezolid Desacetamide Hydroxy Impurity) 168828‐82‐8
3‐chloro‐2‐hydroxypropyl butanoate 3478‐20‐4
Linezolid N‐Desacetyl (R)‐Isomer 912359‐80‐9
Linezolid Descarbonyl (S)‐Isomer 1561176‐27‐9
Linezolid Descarbonyl N‐Desacetyl N‐Acetyl Impurity
333753‐69‐8
1391068‐25‐9
Product: LIOTHYRONINE IMPURITIES
Liothyronine EP Impurity A (Levothyroxine)
51‐48‐9
55‐03‐8
25416‐65‐3
Liothyronine EP Impurity B 300‐39‐0
Liothyronine EP Impurity C (Triiodothyroacetic Acid/ Levothyroxine EP Impurity C/ Levothyroxine T3‐Acetic Acid) 51‐24‐1
Liothyronine EP Impurity D (Tetraiodothyroacetic Acid/ Levothyroxine EP Impurity D/ T4‐Acetic Acid) 67‐30‐1
Liothyronine EP Impurity E (Levothyroxine EP Impurity E/ Diiodothyronine/ 3,5‐Diiodo‐L‐thyronine) 1041‐01‐6
Product: LISINOPRIL IMPURITIES
Lisinopril EP Impurity A (Lisinopril CPP Impurity/ Lisinopril APBA Impurity) 1012‐05‐1
Lisinopril EP Impurity B (Tizanidine EP Impurity I, Anastrozole EP Impurity F, Sultamicillin EP Impurity B)
104‐15‐4
6192‐52‐5
Lisinopril EP Impurity C/ Lisinopri Related Compund A (Lisinopril (S,S,S)‐Diketopiperazine) 328385‐86‐0
Lisinopril EP Impurity D (Lisinopril (S,S,R)‐Diketopiperazine) 219677‐82‐4
Lisinopril EP Impurity E/ Lisinopril (1R)‐Epimer (Lisinopril (R,S,S)‐Isomer)
85955‐59‐5
1356019‐70‐9
Lisinopril EP Impurity F (Lisinopril Cyclohexyl Analog) 1132650‐67‐9
Lisinopril EP Impurity G (lisinopril Dimer) 1356839‐89‐8
Lisinopril EP Impurity H (Lisinopril CPP Lysine Impurity/ Lisinopril Des‐Proline Impurity) 138247‐43‐5
Lisinopril EP Impurity I (N‐Alkyl lisinopril) 927819‐64‐5
Product: LOMUSTINE IMPURITIES
Lomustine Related Compound B 13908‐11‐7

Lomustine Related Compound C 2387‐23‐7
cis‐4‐Hydroxy‐lomustine 52049‐26‐0
trans‐4‐Hydroxy‐lomustine 56239‐24‐8
Product: LOPERAMIDE IMPURITIES
Loperamide EP Impurity A 1391052‐94‐0
Loperamide EP Impurity B
Loperamide EP Impurity C 39512‐49‐7
Loperamide EP Impurity D 37743‐41‐2
Loperamide EP Impurity F/ Loperamide Related Compound F (Loperamide N‐Oxide) 106900‐12‐3
Loperamide EP Impurity G 109572‐89‐6
Loperamide EP Impurity H 61299‐42‐1
Dimethyl‐(tetrahydro‐3,3‐diphenyl‐2‐furilidine)ammonium Bromide 37743‐18‐3
Product: LOPINAVIR IMPURITIES
Lopinavir 4‐Oxo Analog/ Lopinavir Metabolite M1 192725‐39‐6
Lopinavir 4‐Hydroxy Analog 357275‐54‐8
4,5‐Dehydro(pyrimidin‐2(1H)‐one) Lopinavir
Product: LORATIDINE IMPURITIES
Loratidine EP Impurity A/ Loratidine Related Compound F 133284‐74‐9
Loratidine EP Impurity B/ Loratidine Related Compound C 31251‐41‐9
Loratadine EP Impurity C/ Loratadine Related Compound G 165739‐83‐3
Loratidine EP Impurity D/ Loratidine Related Compound A (Desloratadine) 100643‐71‐8
Loratadine EP Impurity E 170727‐59‐0
Loratadine EP Impurity F 125743‐80‐8
Loratidine EP Impurity G/ Loratidine Related Compound B (N‐Methyl Desloratadine/ 8‐Chloro Azatadine) 38092‐89‐6
Loratadine EP Impurity H 29976‐53‐2
Loratidine Related Compound D (Desloratadine 11‐Hydroxy N‐Methyl Impurity) 38089‐93‐9
Loratidine Related Compound E (Loratadine Dichloro Impurity) 133330‐60‐6
Loratadine Related Compound I (Dehydro Loratadine) 133330‐56‐0
Loratadine impurity A (Desloratadine Deschloro Impurity/ N‐Desmethyl Azatadine) 38092‐95‐4

Loratadine N‐Formyl Impurity (Desloratadine Related Compound F/ Desloratadine N‐Formyl Impurity) 117810‐61‐4
Desloratadine 8‐Bromo‐N‐Methyl Impurity 130642‐57‐8
Desloratadine Related Compound A (Desloratadine 8‐Bromo Analog) 117796‐50‐6
Loratadine 8‐Bromo Impurity 130642‐60‐3
Loratadine Methanone Impurity (Desloratadine Methanone Impurity/ Desloratadine Ketone Impurity) 119770‐60‐4
Loratadine N‐Oxide 165739‐62‐8
Loratadine Desethoxycarbonyl 3‐Hydroxy Impurity (Desloratadine 3‐Hydroxy Impurity) 119410‐08‐1
Product: LORCASERIN IMPURITIES
(S)‐Lorcaserin
616202‐81‐4
1006037‐59‐7
Product: LOSARTAN IMPURITIES
Losartan EP Impurity A 79047‐41‐9
Losartan EP Impurity B (Losartan Hydroxy Impurity/ Irbesartan Hydroxy Impurity/ Candesartan Hydroxy Impurity) 160514‐13‐6
Losartan EP Impurity C (Losartan 5‐Chloro Isomer/ Isolosartan)
114799‐13‐2
860644‐28‐6
Losartan EP Impurity D/ Losartan Related Compund A 83857‐96‐9
Losartan EP Impurity E (Losartan Methyl Impurity/ Irbesartan EP Impurity E/ Irbesartan Methyl Impurity/ Candesartan
Methyl Impurity) 120568‐11‐8
Losartan EP Impurity F (Losartan Isopropyl Ether) 1332713‐64‐0
Losartan EP Impurity G (Triphenylmethanol/ Trityl Alcohol/ Candesartan Trityl Alcohol Impurity/ Irbesartan
Triphenylmethanol Impurity/ Zidovudine EP Impurity D) 76‐84‐6
Losartan EP Impurity H (N2‐Trityl Losartan) 133909‐99‐6
Losartan EP Impurity I (O‐Trityl Losartan/ Losartan Trityl Ether) 1006062‐28‐7
Losartan EP Impurity J/ Losartan Related Compound B (Losartan Acetate/ O‐Acetyl Losartan) 1006062‐27‐6
Losartan EP Impurity K/ Losartan Related Compound C (Losartan Aldehyde) 114798‐36‐6
Losartan EP Impurity L/ Losartan Related Compound D (Losartan N1‐Dimer ; N1‐Losartanyl Losartan) 230971‐71‐8
Losartan EP Impurity M/ Losartan Related Compound E (Losartan N2‐Dimer/ N2‐Losartanyl Losartan) 230971‐72‐9

Losartan Related Compound A 124750‐67‐0
Losartan Related Compound B 114772‐55‐3
Losartan Bromo N1 Trityl Impurity/ Olmesartan Impurity N‐(Triphenylmethyl)‐5‐(4’‐bromomethylbiphenyl‐2‐
yl)tetrazole 124750‐51‐2
Losartan Tritylated Dibromo Impurity/ Olmesartan Impurity 2 358685‐13‐9
Losartan Carboxylic Acid (Losartan Carboxylate) 124750‐92‐1
Losartan Dibromomethyl Impurity (Irbesartan Dibromomethyl Impurity/ Valsartan Dibromomethyl Impurity) 209911‐63‐7
Losartan Bromo N1 Trityl Impurity 124750‐51‐2
Losartan Dibromo N2‐Trityl Impurity (Irbesartan Dibromo N2‐Trityl Impurity/ Candesartan Dibromo N2‐Trityl Impurity/
Candesartan Dibromo TTBB Impurity/ Olmesartan Dibromo N2‐Trityl Impurity/ Valsartan Dibromo N2‐Trityl Impurity) 151052‐34‐5
N1‐Trityl Losartan 124751‐00‐4
Product: LOVASTATIN IMPURITIES
Lovastatin EP Impurity A (Pravastatin Deshydroxy Impurity/ Mevastatin/ Compactin) 73573‐88‐3
Lovastatin EP Impurity B (Lovastatin Hydroxy Acid)
75225‐51‐3
75225‐50‐2
Lovastatin EP Impurity C (Anhydro Lovastatin) 109273‐98‐5
Lovastatin Lactone Diol (Simvastatin EP Impurity H/ Simvastatin Lactone Diol) 79952‐42‐4
Product: LOXAPINE IMPURITIES
Loxapine Related Compound A (3‐Chloro Loxapine) 3454‐96‐4
Product: LUMEFANTRINE IMPURITIES
Lumefantrine Impurity A 1331642‐68‐2
2,7‐Dichloro‐9‐[(4‐chlorophenyl)methylene]‐9H‐fluorene 4364‐35‐6
Lumefantrine Desbutyl Impurity 355841‐11‐1
Product: LURASIDONE IMPURITIES
Lurasidone Sulfoxide 1809325‐45‐8
Lurasidone Sulfone 1644295‐09‐9
exo‐2,3‐Norbornanedicarboxylic Acid Monoamide 1365987‐23‐0
Lurasidone Open‐Ring Acid (1S,2R,3S,4R)‐Isomer 1644295‐07‐7
(+)‐trans‐1,2‐Cyclohexanedimethanol 3205‐34‐3

exo‐2,3‐Norbornanedicarboximide 14805‐29‐9
3‐[4‐(methylsulfonyl)‐1‐piperazinyl]‐1,2‐Benzisothiazole 2190680‐18‐1
Lurasidone DBI Piperazine Impurity (Ziprasidone EP Impurity P) 223586‐82‐1
((1R,2R)‐cyclohexane‐1,2‐diyl)bis(methylene) dimethanesulfonate 186204‐35‐3
(1R,2R)‐1,2‐cyclohexanedimethanol 65376‐05‐8
3‐Chloro‐1,2‐benzisothiazole 7716‐66‐7
Product: LYMECYCLINE IMPURITIES
Lymecycline EP Impurity G
57‐62‐5
64‐72‐2
Lymecycline EP Impurity H 64‐75‐5
Product: MACITENTAN IMPURITIES
2‐[[6‐Amino‐5‐(4‐bromophenyl)‐4‐pyrimidinyl]oxy]‐ethanol 2211059‐05‐9
6‐Amino‐5‐(4‐bromophenyl)‐4(3H)‐pyrimidinone 2211054‐46‐3
5‐(4‐Bromophenyl)‐4,6‐dichloropyrimidine 146533‐41‐7
5‐Des‐bromo‐macitentan 2211059‐00‐4
Dimethyl (4‐Bromophenyl)malonate 149506‐35‐4
N‐Propylsulfamide Potassium Salt 1393813‐41‐6
Macitentan N‐Despropyl‐N‐Methyl Impurity/ Macitentan N‐methyl Analog 441798‐25‐0
Macitentan N‐Despropyl‐N‐Ethyl Impurity/ Macitentan N‐Ethyl Analog 441796‐13‐0
Product: MANNITOL IMPURITIES
sorbitol 50‐70‐4
Maltitol 585‐88‐6
Product: MEBENDAZOLE IMPURITIES
Mebendazole EP Impurity A/ Mebendazole Related Compound A (Mebendazole Amine Impurity) 52329‐60‐9
Mebendazole EP Impurity B/ Mebendazole Related Compound B (Mebendazole 2‐Hydroxy) 21472‐33‐3
Mebendazole EP Impurity C/ Mebendazole Related Compound C 66066‐76‐0
Mebendazole EP Impurity D/ Mebendazole Related Compound D (Mebendazole 1‐Methyl) 132119‐11‐0
Product: MEBEVERINE IMPURITIES
Mebeverine EP Impurity D 93‐07‐2

Product: MECLIZINE IMPURITIES
Meclizine Related Compound A (Cetirizine 4‐Chlorobenzhydrol Impurity) 119‐56‐2
Product: MEDETOMIDINE IMPURITIES
Medetomidine Hydroxy Impurity 86347‐12‐8
Medetomidine Hydroxy N‐Benzyl Impurity 2250243‐44‐6
Medetomidine N‐Benzyl Impurity 2250242‐52‐3
Medetomidine Ethyl Impurity
Product: MEFENAMIC ACID IMPURITIES
Mefenamic Acid EP Impurity A
87‐59‐2
5417‐45‐8
Mefenamic Acid EP Impurity B 21122‐68‐9
Mefenamic Acid EP Impurity C (Mesalazine EP Impurity L) 118‐91‐2
Mefenamic Acid EP Impurity D (Metronidazole Benzoate EP Impurity C/ Tiaprofenic Acid EP Impurity D/ Glycopyrrolate
EP Impurity D) 65‐85‐0
Mefenamic Acid EP Impurity E 4869‐11‐8
Product: MEFLOQUINE IMPURITIES
Mefloquine EP Impurity A 35853‐55‐5
Mefloquine EP Impurity B (Dehydro Mefloquine) 68496‐04‐8
Mefloquine EP Impurity C
58737‐31‐8
58560‐52‐4
Product: MELATONIN IMPURITIES
Melatonin Related Compound A (N‐Desacetyl Melatonin/ 5‐Methoxytryptamine) 608‐07‐1
N‐(3‐(2‐formamido‐5‐methoxyphenyl)‐3‐oxopropyl)acetamide 52450‐38‐1
2‐(5‐methoxy‐1H‐indol‐3‐yl)ethanamine hydrochloride 66‐83‐1
Product: MELOXICAM IMPURITIES
Meloxicam EP Impurity A/ Meloxicam Related Compund A (Piroxicam EP Impurity K)
113913‐36‐3
24683‐26‐9
Meloxicam EP Impurity B/ Meloxicam Related Compund B 7305‐71‐7
Meloxicam EP Impurity C 1262333‐25‐4
Meloxicam EP Impurity D 1331636‐17‐9

Meloxicam EP Impurity E (Piroxicam EP Impurity J) 35511‐15‐0
Meloxicam EP Impurity F/ Meloxicam Related Compund C (Piroxicam EP Impurity L) 118854‐48‐1
Meloxicam Related Compund D (O‐Methyl Meloxicam/ 4‐Methoxy Meloxicam)
Amido Ethyl Meloxicam 881399‐30‐0
Amido Methyl Meloxicam 892395‐41‐4
Product: MELPHALAN IMPURITIES
Melphalan EP Impurity H (Melphalan Methyl Ester) 88457‐23‐2
Melphalan Mono‐chloroethyl 573704‐41‐3
Melphalan EP Impurity D (Hydroxy Melphalan) 61733‐01‐5
Product: MEMANTINE IMPURITIES
Memantine Related Compund A (1,3‐Dimethyladamantane) 702‐79‐4
Memantine Related Compund B (3,5‐Dimethyladamantane‐1‐ol) 707‐37‐9
Memantine Related Compund C (1‐Chloro‐3,5‐dimethyladamantane) 707‐36‐8
Memantine Related Compund D (1‐Bromo‐3,5‐dimethyladamantane) 941‐37‐7
Memantine Related Compund E (N‐3,5‐Dimethyladamantan‐1‐yl formamide) 351329‐88‐9
Memantine Related Compund F
63971‐25‐5
356572‐08‐2
Memantine Related Compund G (Desmethyl Memantine) 33103‐93‐4
Amantadine Hydrochloride 665‐66‐7
N‐Acetyl Memantine 19982‐07‐1
Adamantane 281‐23‐2
Memantine N‐oxide 1262583‐10‐7
1,3,5‐Trimethyladamantane 707‐35‐7
1‐Methyl Adamantane 768‐91‐2
Product: MEPHENESIN IMPURITIES
Chlorphenesin 104‐29‐0
Product: MEPIVACAINE IMPURITIES
Mepivacaine EP Impurity A (Ropivacaine EP Impurity H/ Ropivacaine Related Compound A (Lidocaine EP Impurity A/
Lidocaine Related Compound A/ Bupivacaine EP Impurity F)
87‐62‐7
21436‐98‐6

Mepivacaine EP Impurity B (Bupivacaine EP Impurity B/ Bupivacaine Related Compound B/ N‐Desbutyl Bupivacaine)
15883‐20‐2
65797‐42‐4
Mepivacaine EP Impurity C (Bupivacaine EP Impurity A) 39627‐98‐0
Product: MEPYRAMINE IMPURITIES
Mepyramine EP Impurity C (Tenoxicam EP Impurity A/ Piroxicam EP Impurity A/ 2‐Aminopyridine) 504‐29‐0
Product: MESALAMINE IMPURITIES/ MESALAZINE IMPURITIES
Mesalazine EP Impurity B 591‐27‐5
Mesalazine EP Impurity C 95‐55‐6
Mesalazine EP Impurity D 99‐05‐8
Mesalazine EP Impurity E 65‐49‐6
Mesalazine EP Impurity F 570‐23‐0
Mesalazine EP Impurity G 490‐79‐9
Mesalazine EP Impurity H (Lamivudine EP Impurity C/ Acetylsalicylic Acid EP Impurity C/ Salicylic Acid/ Sulfasalazine EP
Impurity H) 69‐72‐7
Mesalazine EP Impurity I 3147‐53‐3
Mesalazine EP Impurity J 112725‐89‐0
Mesalazine EP Impurity K (Trimethoprim EP Impurity K) 62‐53‐3
Mesalazine EP Impurity L (Mefenamic Acid EP Impurity C) 118‐91‐2
Mesalazine EP Impurity M 2516‐96‐3
Mesalazine EP Impurity N 96‐97‐9
Mesalazine EP Impurity P 887256‐40‐8
Mesalazine EP Impurity Q 3970‐35‐2
Mesalazine EP Impurity R 85‐38‐1
Mesalazine EP Impurity S 1797983‐23‐3
Mesalazine N‐Acetyl Impurity 51‐59‐2
Mesalazine N‐β‐D‐Glucoside 123135‐21‐7
Product: MESNA IMPURITIES
Mesna EP Impurity A 25985‐57‐3
Product: METAMIZOLE IMPURITIES

Metamizole EP Impurity A (4‐Formylamino Antipyrine) 1672‐58‐8
Metamizole EP Impurity B (4‐Aminophenazone) 83‐07‐8
Metamizole EP Impurity C (4‐Methylamino Antipyrine)
519‐98‐2
856307‐27‐2
Metamizole EP Impurity D (4‐Dimethylamino Antipyrine) 58‐15‐1
Product: METAXALONE IMPURITIES
Metaxalone Impurity A 59365‐66‐1
Metaxalone Related Compound B 66766‐07‐2
Metaxalone Mono Impurity 1392430‐16‐8
Metaxalone Oxirane Impurity 4287‐30‐3
3,5‐Dimethylphenol 108‐68‐9
Product: METFORMIN IMPURITIES
Metformin EP Impurity A/ Metformin Related Compound A (1‐Cyanoguanidine) 461‐58‐5
Metformin EP Impurity B (Guanylmelamine)
4405‐08‐7
2959‐04‐8
Metformin EP Impurity C/ Metformin Related Compound C (1‐Cyanoguanidine) 1985‐46‐2
Metformin EP Impurity D (Melamine) 108‐78‐1
Metformin EP Impurity E/ Metformin Related Compound B (N‐Desmethyl Metformin)
1609‐00‐3
36801‐25‐9
1674‐62‐0
Metformin EP Impurity F (Imatinib EP Impurity I/ Dacarbazine EP Impurity D) 506‐59‐2
Product: METHOCARBAMOL IMPURITIES
Methocarbamol B‐Isomer 10488‐39‐8
Methocarbamol Dioxolone (rac Guaifenesin Cyclic Carbonate) 2049‐21‐0
Product: METHOTREXATE IMPURITIES
Methotrexate EP Impurity A
945‐24‐4
73978‐41‐3
Methotrexate EP Impurity D 5623‐18‐7
Methotrexate EP Impurity E 19741‐14‐1
Methotrexate EP Impurity H (Methotrexate 5‐Methyl Ester) 67022‐39‐3

Methotrexate EP Impurity J (Methotrexate Dimethyl Ester) 34378‐65‐9
Methotrexate EP Impurity K (Folic Acid EP Impurity A) 4271‐30‐1
Methotrexate EP Impurity L 52980‐68‐4
Product: METHOXSALEN IMPURITIES
2‐Chloro‐1‐(2,3,4‐trihydroxyphenyl)ethan‐1‐one 17345‐68‐5
3‐Bromophthalide 6940‐49‐4
6,7‐Dihydroxycoumeranone 6272‐27‐1
4',5'‐Dihydro‐8‐hydroxypsoralen 68123‐30‐8
4',5'‐Dihydro‐8‐methoxypsoralen .3779‐03‐1
Product: METHYLPREDNISOLONE IMPURITIES
Methylprednisolone Acetate EP Impurity E (Hydrocortisone Acetate EP Impurity C/ Prednisolone EP Impurity C) 52‐21‐1
Product: METOCLOPRAMIDE IMPURITIES
Metoclopramide EP Impurity A/ Metoclopramide Related Compound A (N‐Acetyl Metoclopramide) 5608‐13‐9
Metoclopramide EP Impurity E 100‐36‐7
Metoclopramide EP Impurity F (O‐Desmethyl Metoclopramide)
38339‐95‐6
38059‐78‐8
Metoclopramide EP Impurity G (Metoclopramide N‐Oxide) 171367‐22‐9
Metoclopramide EP Impurity H 50‐86‐2
Product: METOLAZONE IMPURITIES
Metolazone EP Impurity A 50869‐25‐5
Metolazone EP Impurity B 28508‐63‐6
Metolazone EP Impurity C (Desmethyl Metolazone) 28524‐40‐5
Metolazone EP Impurity D (3,4‐Didehydro Metolazone) 4015‐23‐0
Metolazone EP Impurity E (Metolazone Benzamide Analog) 23380‐54‐3

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OPULENT PHARMA IMPURITY STOCK LIST (D-M)