Olympus Chemicals & Fertilizers is an India-based company that manufactures and supplies pharmaceutical impurities, metabolites, and custom synthesis services. It has highly qualified scientific staff and focuses on quality, timely delivery, and client satisfaction. The company has facilities for organic synthesis and analytical testing. It provides products with certificates of analysis and comprehensive analytical data. It maintains an inventory of over 1000 impurities with 5-8 added each month.
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API, Pharmacopoeia Impurities | Olympus Impurities Standard Suppliers
1. OLYMPUS CHEMICALS & FERTILIZERS
IN BUSINESS FOR SCIENCE AND INNOVATION
MANUFACTURER OF PHARMACEUTICAL IMPURITY STANDARD & METABOLITE, CUSTOM SYNTHESIS
INTRODUCTION
Olympus Chemical & fertilizers is India based company doing business in manufacturing and supply of
certified pharmacopeia impurities, process impurities, metabolites, degradation impurities and custom
synthesis services.
Our ability to deliver high quality services and solutions to pharmaceutical industry in India as well as
abroad
OUR STRENGTH
Highly qualified staff of scientist and chemist.
Quality & Trust are the two hands of our business.
Effective communication with clients.
Focus on timely delivery of products & caring about clients timeline.
Always believe in team work and strong association.
2. OLYMPUS CHEMICALS & FERTILIZERS
IN BUSINESS FOR SCIENCE AND INNOVATION
MANUFACTURER OF PHARMACEUTICAL IMPURITY STANDARD & METABOLITE, CUSTOM SYNTHESIS
OUR FACILITIES -
Facilities for all kind of ORGANIC SYNTHESIS
Facilities for analytical testing - Shimadzu LC solution HPLC, Shimadzu LC solution
preparative HPLC, Lyophilizer, UV Spectrophotometer Shimadzu, Melting Point apertures,
KF and other small instruments.
Facilities of storage from Room temperature – freeze temperature to -20C is available.
Facilities for Fast track currier services for domestic as well as abroad is available.
Facilities of packing in high recovery vial for solid as well as liquid compound is available
3. OLYMPUS CHEMICALS & FERTILIZERS
IN BUSINESS FOR SCIENCE AND INNOVATION
OUR SERVICES -
Our services to pharmaceuticals industries, formulation industries, chemicals industries, research
institute, R&D labs, academic institution in India as well as abroad.
Our services in delivery of high quality products with certified COA and comprehensive analytical data.
Our services to provide complete technical support not only to our clients but to all.
Our services to fast and promote reply to RFQ with best price and best timeline.
4. TIME TO TAKE A LOOK ON INVENTEORY
OLYMPUS INVENTEORY SYSTEM (OIS) < 1000 IMPURITIES IN STOCK, 5-8 ADDED EVERY MONTH
AZITHROMYCIN IMPURITIES CYCLOSERINE IMPURITIES MONTULUKAST
IMPURITIES
ACYCLOVIR IMPURITIES DAREFENACIN IMPURITIES QUETIAPINE
IMPURITIES
AMBROXOL IMPURITIES DRONEDARON IMPURITIES RASAGALINE IMPURITIES
ARRIPIPRAZOLE IMPURITIES DEXMEDITOMDINE IMPURITIES ROPINIROL
IMPURITIES
BUSPIRONE IMPURITIES GABAPENTENE IMPURITIES SOLIFINACIN IMPURITIES
CANDESARTAN IMPURITIES HYDROCORTISONE IMPURITIES TELMISARTAN IMPURITIES
CARVEDILOL IMPURITIES LEVOTHYROXINE IMPURITIES TRAZADONE IMPURITIES
CINACALCET IMPURITIES LORATIDINE IMPURITIES
5. WE OFFER – WITH PRODUCTS
• Products with excellent packing and clear labeling
• Certificate of analysis
• HNMR with proper Interpretation
• 13CNMR with proper Interpretation
• Mass / LC_MS
• HPLC (By pharmacopeia or In-house method)
• IR
• TGA
• UV
If any more extra data we will be provide on request
OLYMPUS CHEMICALS & FERTILIZERS
IN BUSINESS FOR SCIENCE AND INNOVATION
6. CERTIFICATE OF ANALYSIS
AZITHROMYCIN IMPURITY C
3′-O-DEMETHYLAZITHROMYCIN
Product Number No 11-OLY0020.03
CAS Number: N.A. Long-term Storage: 2-8 0C
Lot Number: AZI-C-16 Appearance: Off White Solid
Molecular Formula: C37H70N2O12 Melting Point: N.A.
Molecular Weight: 734.98 g/mol Purity by HPLC: 94.01%
Manufacturing date: September-28-2016
Re-Test Date: September-28-2018
This certificate is valid for two years from the date of shipment
Provided the substance is stored under the recommended conditions.
7. I. IDENTITY
THE IDENTITY OF THE
REFERENCE SUBSTANCE
WAS ESTABLISHED BY
FOLLOWING ANALYSES.
IA. 1H-NMR SPECTRUM
CONDITIONS: BRUKER 400
MHZ, DMSO-D6
THE STRUCTURE IS
CONFIRMED WITH THE
SIGNALS OF THE
SPECTRUM AND THEIR
INTERPRETATION
8. IC. IR SPECTRUM
METHOD: ATTENUATED
TOTAL REFLECTION
FOURIER TRANSFORM
INFRARED (ATR-FTIR)
SPECTROSCOPY.
INSTRUMENT: BRUKER
MODEL ALPHA.
IB. MASS SPECTRUM
METHOD: AGILENT LC-,
MODEL 1200 INFINITY
SERIES: AGILENT MS,
MODEL 6120
9. II. PURITY
THE PURITY OF THE REFERENCE SUBSTANCE WAS ANALYZED BY SHIMADZU SCL-10AVP HIGH
PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC).
HPLC Conditions:
Solution A: 1.80 g/l solution of disodium hydrogen phosphate, pH adjusted to 8.9
using dilute phosphoric acid or dilute sodium hydroxide.
Solution B: Methanol: Acetonitrile (250:750 V/V)
Diluent: 1.73g/l solution of ammonium dihydrogen phosphate adjusted pH 10.0
using ammonia, Transfer 350ml of this solution to suitable container. Add 300 ml
of acetonitrile and 350 ml methanol. Mix well and sonicate.
Column: Conditions: Detector: Injector:
Gemini Gold (C18) 1.0 ml/min, 210nm/UV Manual
5 μm, 150 x 4.6 mm 0-25 min A/B 50-55 50µl
25-30 min A/B 55-60
30-80 min A/B 60-75
80-92 min A/B 75-50 (v/v)
10. Relative Retention Time
(RRT) Calculation –
Retention Time of Impurity
(RT)/Retention (RT) Time of
API. (44.660/60.378 =
0.73)
Results:
Purity: 94.01 %
Method: Azithromycin USP
API RT: 60.378
Observed RRT: 0.73
Reported RRT: 0.73
12. REVIEWED BY
HEAD OF QA & QC
APPROVED BY
MANAGENING DIRECTOR
IV. Residual Solvents
Method: 1H-NMR
No significant amounts of residual solvents were detected (< 0.05 %).
V. Potency
%Potency = (Chromatographic purity – TGA Value) = (94.01-3.862) = 90.14%
VI. Final Result
Total impurities (HPLC) 5.983 %
Water Content: 3.862%
Purity by HPLC: 94.01
Residual solvents: < 0.05 %
Potency: 90.14%
Release Date: 2016-10-10
13. OLYMPUS CHEMICALS & FERTILIZERS
IN BUSINESS FOR SCIENCE AND INNOVATION
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