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IPQC and FPQC test for opthalmic preparation as per IP, BP
ANIPQC D USP
Chitra Paytode, Roshan Telrandhe*
Dadasaheb Balpande college of Pharmacy, Nagpur, Maharashtra, India
Ophthalmic preparation are the sterile liquid or semisolid preparation meant to
installation in to the eyes in the space between eye lids and eye ball .
These product must be sterile and are prepare under the same condition as that of
parenteral preparation
1. REFERENCES
2. Telrandhe R. Nanotechnology for cancer therapy: Recent developments. Eur J Pharm Med
Res. 2016;3(11): 284-294.
3. Telrandhe R, Mahapatra D K, Kamble M A. Bombax ceiba thorn extract mediated synthesis
of silver nanoparticles: Evaluation of anti-Staphylococcus aures activity. Int J Pharm Drug
Anal. 2017;5(9): 376-379.
4. Shende V, Telrandhe R. Formulation and evaluation of Tooth Gel from Aloe vera leaves
extract. Int J Pharm Drug Anal. 2017;5(10): 394-398.
5. Deshmukh P, Telrandhe R, Gunde M. Formulation and Evalua-tion of Herbal Toothpaste:
Compared With Maeketed Preparation. Int J Pharm Drug Anal. 2017;5(10): 406-410.
6. Telrandhe R, Deshmukh P, Gunde M. Formulation and Evalua-tion of Herbal Toothpaste:
Compared With Maeketed Preparation. Int J Pharm Drug Anal. 2017;5(10): 406-410.
7. Trivedi L, Telrandhe R, Dhabarde D. Differential spectrophotometric method for estimation
and validation of Verapamil in Tablet dosage form. Int J Pharm Drug Anal. 2017;5(11): 419-
422.
8. Nanotechnology for Cancer therapy: Recent developments
https://www.researchgate.net/publication/321669196_Nanotechnology_for_Cancer_therapy_
Recent_developments
9. Nanoparticle of plant extract: A Novel approach for cancer therapy
https://www.researchgate.net/publication/321641952_Nanoparticle_of_plant_extract_A_Nove
l_approach_for_cancer_therapy
10. Nanoparticle of plant extract: A Novel approach for cancer therapy
https://www.researchgate.net/publication/315654928_Nanoparticle_of_plant_extract_A_Nove
l_approach_for_cancer_therapy
11. Bombax ceiba thorn extract mediated synthesis of silver nanoparticles: Evaluation of anti-
Staphylococcus aureus activity
https://www.researchgate.net/publication/321682787_Bombax_ceiba_thorn_extract_mediated
_synthesis_of_silver_nanoparticles_Evaluation_of_anti-Staphylococcus_aureus_activity
12. Formulation and Evaluation of Tooth Gel from Aloe vera leaves extract
https://www.researchgate.net/publication/321730188_Formulation_and_Evaluation_of_Tooth
_Gel_from_Aloe_vera_leaves_extract
Presented in NATIONAL CONFERENCE ;A Phytomedicine : A Novel
Approach For Cancer Treatment.
Sponsered By Indian Councial Of Medical Research, Delhi.
Organised By Kamla Nehru College Of Pharmacy, Butibori, Nagpur-
441108, Maharastra, India.
ON 25 & 26 March 2017
The formulation which are taken into consideration are as fallow
1. EYE DROP 2. EYE LOTION
Eye ointments are sterile preparation meant for application to the eye.
These are prepared under aseptic conditions and packed in sterile collapsible tubes
which keep the preparation sterile until whole of it is consumed.
Ophthalmic suspensions are not commonly used as compared to eye drops.
They are prepared only in those cases , when the drug is insoluble in the desired
vehicle or unstable in liquid form.
_Gel_from_Aloe_vera_leaves_extract
13. Formulation and Evaluation of Herbal Toothpaste: Compared with marketed preparation
https://www.researchgate.net/publication/321731107_Formulation_and_Evaluation_of_Herba
l_Toothpaste_Compared_with_marketed_preparation
14. Formulation and Evaluation of Herbal Toothpaste: Compared with marketed preparation
https://www.researchgate.net/publication/321731318_Formulation_and_Evaluation_of_Herba
l_Toothpaste_Compared_with_marketed_preparation
15. Differential spectrophotometric method for estimation and validation of Verapamil in Tablet
dosage form
https://www.researchgate.net/publication/321731238_Differential_spectrophotometric_metho
d_for_estimation_and_validation_of_Verapamil_in_Tablet_dosage_form
16. NOVEL IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP
ANIPQC D USP
https://www.researchgate.net/publication/321731200_NOVEL_IPQCL_AND_FPQC_TEST_
FOR_OPTHALMIC_PREPARATION_AS_PER_IP_BP_ANIPQC_D_USP
17. Nanoparticle of plant extract: A Novel approach for cancer therapy
https://www.researchgate.net/publication/321731633_Nanoparticle_of_plant_extract_A_Nove
l_approach_for_cancer_therapy
18. Differential spectrophotometric method for estimation and validation of Verapamil in Tablet
dosage form
https://www.researchgate.net/publication/321731547_Differential_spectrophotometric_metho
d_for_estimation_and_validation_of_Verapamil_in_Tablet_dosage_form
19. NANOTECHNOLOGY FOR CANCER THERAPY: RECENT DEVELOPMENTS
https://www.researchgate.net/publication/321731657_NANOTECHNOLOGY_FOR_CANCE
R_THERAPY_RECENT_DEVELOPMENTS
20. Bombax ceiba thorn extract mediated synthesis of silver nanoparticles: Evaluation of anti-
Staphylococcus aureus activity
https://www.researchgate.net/publication/321731559_Bombax_ceiba_thorn_extract_mediated
_synthesis_of_silver_nanoparticles_Evaluation_of_anti-Staphylococcus_aureus_activity
21. Formulation and Evaluation of Tooth Gel from Aloe vera leaves extract
https://www.researchgate.net/publication/321731503_Formulation_and_Evaluation_of_Tooth
_Gel_from_Aloe_vera_leaves_extract
22. Formulation and Evaluation of Herbal Toothpaste: Compared with marketed preparation
https://www.researchgate.net/publication/321731742_Formulation_and_Evaluation_of_Herba
l_Toothpaste_Compared_with_marketed_preparation
23. Formulation and Evaluation of Herbal Toothpaste: Compared with marketed preparation
https://www.researchgate.net/publication/321731838_Formulation_and_Evaluation_of_Herba
l_Toothpaste_Compared_with_marketed_preparation
24. Differential spectrophotometric method for estimation and validation of Verapamil in Tablet
dosage form
https://www.researchgate.net/publication/321731932_Differential_spectrophotometric_metho
d_for_estimation_and_validation_of_Verapamil_in_Tablet_dosage_form
3. EYE OINTMENT 4. EYE SUSPENSION
Eye drops are sterile aqueous or suspension of drug that are instilled into
the eye with a dropper .
They usually contain drugs having antiseptic , anti inflammatory and
mydriatic properties
Eye lotions are the sterile aqueous solution used for washing of the eyes.
The eye lotion are supplied in concentrated and are required to be diluted
with warm water immediately before use.
In-process material should be tested for identity,
quality, purity, and
• streng In-process quality control test
j perform during manufacturing
• of drug product.
•The both in-process and finished product
quality control test involves stringent
•quality control test to make products totally
meeting the specification before they are
release into market.
These test is applicable for eye drops and eye ointment.
uitable volume of eye drops into a counting cell or onto a microscope an area
corresponding to 10 microgram per ml of solid phase .
According to IP Not more than 20 particles have a maximum dimension greater
than 25 micrometer .
And not more than 10 particles have a maximum dimension grater than 50
micrometer.
As started by BP this test appropriate for Powder for the preparation of eye drops and eye
lotions are supplied in a dry , sterile from to be dissolved or suspended in an appropriate
liquid vehicle at the time of administration . They may contain excipients to facilitate
dissolution or dispersion , to prevent the caking .
 10 dosage units taken at random.
The preparation complies with the test if not more then one individual content is outside
the limits of 85 % to 115 % of the average content and none is outside the limits of 75 %to
125 % average content .
The preparation fail , if one or more individual contents are outside the limits of 75% to
115%of average content.

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IPQC and FPQC test for opthalmic preparation as per IP, BP ANIPQC D USP

  • 1. IPQC and FPQC test for opthalmic preparation as per IP, BP ANIPQC D USP Chitra Paytode, Roshan Telrandhe* Dadasaheb Balpande college of Pharmacy, Nagpur, Maharashtra, India Ophthalmic preparation are the sterile liquid or semisolid preparation meant to installation in to the eyes in the space between eye lids and eye ball . These product must be sterile and are prepare under the same condition as that of parenteral preparation 1. REFERENCES 2. Telrandhe R. Nanotechnology for cancer therapy: Recent developments. Eur J Pharm Med Res. 2016;3(11): 284-294. 3. Telrandhe R, Mahapatra D K, Kamble M A. Bombax ceiba thorn extract mediated synthesis of silver nanoparticles: Evaluation of anti-Staphylococcus aures activity. Int J Pharm Drug Anal. 2017;5(9): 376-379. 4. Shende V, Telrandhe R. Formulation and evaluation of Tooth Gel from Aloe vera leaves extract. Int J Pharm Drug Anal. 2017;5(10): 394-398. 5. Deshmukh P, Telrandhe R, Gunde M. Formulation and Evalua-tion of Herbal Toothpaste: Compared With Maeketed Preparation. Int J Pharm Drug Anal. 2017;5(10): 406-410. 6. Telrandhe R, Deshmukh P, Gunde M. Formulation and Evalua-tion of Herbal Toothpaste: Compared With Maeketed Preparation. Int J Pharm Drug Anal. 2017;5(10): 406-410. 7. Trivedi L, Telrandhe R, Dhabarde D. Differential spectrophotometric method for estimation and validation of Verapamil in Tablet dosage form. Int J Pharm Drug Anal. 2017;5(11): 419- 422. 8. Nanotechnology for Cancer therapy: Recent developments https://www.researchgate.net/publication/321669196_Nanotechnology_for_Cancer_therapy_ Recent_developments 9. Nanoparticle of plant extract: A Novel approach for cancer therapy https://www.researchgate.net/publication/321641952_Nanoparticle_of_plant_extract_A_Nove l_approach_for_cancer_therapy 10. Nanoparticle of plant extract: A Novel approach for cancer therapy https://www.researchgate.net/publication/315654928_Nanoparticle_of_plant_extract_A_Nove l_approach_for_cancer_therapy 11. Bombax ceiba thorn extract mediated synthesis of silver nanoparticles: Evaluation of anti- Staphylococcus aureus activity https://www.researchgate.net/publication/321682787_Bombax_ceiba_thorn_extract_mediated _synthesis_of_silver_nanoparticles_Evaluation_of_anti-Staphylococcus_aureus_activity 12. Formulation and Evaluation of Tooth Gel from Aloe vera leaves extract https://www.researchgate.net/publication/321730188_Formulation_and_Evaluation_of_Tooth _Gel_from_Aloe_vera_leaves_extract Presented in NATIONAL CONFERENCE ;A Phytomedicine : A Novel Approach For Cancer Treatment. Sponsered By Indian Councial Of Medical Research, Delhi. Organised By Kamla Nehru College Of Pharmacy, Butibori, Nagpur- 441108, Maharastra, India. ON 25 & 26 March 2017 The formulation which are taken into consideration are as fallow 1. EYE DROP 2. EYE LOTION Eye ointments are sterile preparation meant for application to the eye. These are prepared under aseptic conditions and packed in sterile collapsible tubes which keep the preparation sterile until whole of it is consumed. Ophthalmic suspensions are not commonly used as compared to eye drops. They are prepared only in those cases , when the drug is insoluble in the desired vehicle or unstable in liquid form. _Gel_from_Aloe_vera_leaves_extract 13. Formulation and Evaluation of Herbal Toothpaste: Compared with marketed preparation https://www.researchgate.net/publication/321731107_Formulation_and_Evaluation_of_Herba l_Toothpaste_Compared_with_marketed_preparation 14. Formulation and Evaluation of Herbal Toothpaste: Compared with marketed preparation https://www.researchgate.net/publication/321731318_Formulation_and_Evaluation_of_Herba l_Toothpaste_Compared_with_marketed_preparation 15. Differential spectrophotometric method for estimation and validation of Verapamil in Tablet dosage form https://www.researchgate.net/publication/321731238_Differential_spectrophotometric_metho d_for_estimation_and_validation_of_Verapamil_in_Tablet_dosage_form 16. NOVEL IPQCL AND FPQC TEST FOR OPTHALMIC PREPARATION AS PER IP, BP ANIPQC D USP https://www.researchgate.net/publication/321731200_NOVEL_IPQCL_AND_FPQC_TEST_ FOR_OPTHALMIC_PREPARATION_AS_PER_IP_BP_ANIPQC_D_USP 17. Nanoparticle of plant extract: A Novel approach for cancer therapy https://www.researchgate.net/publication/321731633_Nanoparticle_of_plant_extract_A_Nove l_approach_for_cancer_therapy 18. Differential spectrophotometric method for estimation and validation of Verapamil in Tablet dosage form https://www.researchgate.net/publication/321731547_Differential_spectrophotometric_metho d_for_estimation_and_validation_of_Verapamil_in_Tablet_dosage_form 19. NANOTECHNOLOGY FOR CANCER THERAPY: RECENT DEVELOPMENTS https://www.researchgate.net/publication/321731657_NANOTECHNOLOGY_FOR_CANCE R_THERAPY_RECENT_DEVELOPMENTS 20. Bombax ceiba thorn extract mediated synthesis of silver nanoparticles: Evaluation of anti- Staphylococcus aureus activity https://www.researchgate.net/publication/321731559_Bombax_ceiba_thorn_extract_mediated _synthesis_of_silver_nanoparticles_Evaluation_of_anti-Staphylococcus_aureus_activity 21. Formulation and Evaluation of Tooth Gel from Aloe vera leaves extract https://www.researchgate.net/publication/321731503_Formulation_and_Evaluation_of_Tooth _Gel_from_Aloe_vera_leaves_extract 22. Formulation and Evaluation of Herbal Toothpaste: Compared with marketed preparation https://www.researchgate.net/publication/321731742_Formulation_and_Evaluation_of_Herba l_Toothpaste_Compared_with_marketed_preparation 23. Formulation and Evaluation of Herbal Toothpaste: Compared with marketed preparation https://www.researchgate.net/publication/321731838_Formulation_and_Evaluation_of_Herba l_Toothpaste_Compared_with_marketed_preparation 24. Differential spectrophotometric method for estimation and validation of Verapamil in Tablet dosage form https://www.researchgate.net/publication/321731932_Differential_spectrophotometric_metho d_for_estimation_and_validation_of_Verapamil_in_Tablet_dosage_form 3. EYE OINTMENT 4. EYE SUSPENSION Eye drops are sterile aqueous or suspension of drug that are instilled into the eye with a dropper . They usually contain drugs having antiseptic , anti inflammatory and mydriatic properties Eye lotions are the sterile aqueous solution used for washing of the eyes. The eye lotion are supplied in concentrated and are required to be diluted with warm water immediately before use. In-process material should be tested for identity, quality, purity, and • streng In-process quality control test j perform during manufacturing • of drug product. •The both in-process and finished product quality control test involves stringent •quality control test to make products totally meeting the specification before they are release into market. These test is applicable for eye drops and eye ointment. uitable volume of eye drops into a counting cell or onto a microscope an area corresponding to 10 microgram per ml of solid phase . According to IP Not more than 20 particles have a maximum dimension greater than 25 micrometer . And not more than 10 particles have a maximum dimension grater than 50 micrometer. As started by BP this test appropriate for Powder for the preparation of eye drops and eye lotions are supplied in a dry , sterile from to be dissolved or suspended in an appropriate liquid vehicle at the time of administration . They may contain excipients to facilitate dissolution or dispersion , to prevent the caking .  10 dosage units taken at random. The preparation complies with the test if not more then one individual content is outside the limits of 85 % to 115 % of the average content and none is outside the limits of 75 %to 125 % average content . The preparation fail , if one or more individual contents are outside the limits of 75% to 115%of average content.