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YASH Pharma Laboratories Pvt. LTD.: Certificate of Analysis

This certificate of analysis summarizes the results of quality testing performed on a batch of Ketoconazole BP produced by Danopharm Chemicals Pvt. Ltd. and supplied to YASH Pharma Laboratories Pvt. Ltd. The tests confirm that the white powdered material has the expected solubility, melting point, identification by IR, TLC, and chloride reactions. Related substances and loss on drying were within specifications, and assay was 98.61% of the labeled amount, complying with Indian Pharmacopeia standards.

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252 views1 page

YASH Pharma Laboratories Pvt. LTD.: Certificate of Analysis

This certificate of analysis summarizes the results of quality testing performed on a batch of Ketoconazole BP produced by Danopharm Chemicals Pvt. Ltd. and supplied to YASH Pharma Laboratories Pvt. Ltd. The tests confirm that the white powdered material has the expected solubility, melting point, identification by IR, TLC, and chloride reactions. Related substances and loss on drying were within specifications, and assay was 98.61% of the labeled amount, complying with Indian Pharmacopeia standards.

Uploaded by

shakt londa
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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YASH Pharma Laboratories Pvt. Ltd.

Khasra No.: 19M, Raipur, Bhagwanpur, Roorkee,


Haridwar, Uttarakhand

CERTIFICATE OF ANALYSIS page 1 of 1


Material Name Ketoconazole BP Material Code NA
Batch Number DCPL/17/KTZ/181 GRN Number 8021
A.R Number YRMG170966 Qty. Received 50.00 Kgs.
Specification No. YPR/RMS/QC/031 No. of container 02
DANOPHARM
DANOPHARM CHEMICALS
Manufactured By CHEMICALS Supplied By
PVT.LTD
PVT.LTD
Mfg. Date 12/2017 Exp. Date 11/2022
Date of receive 06/01/2018 Release Date 09/01/2018

Sr. No. Test Specifications Result


1. Description A white or almost white powder. A white powder.
2. Solubility Practically insoluble in water. Practically insoluble in water.
Freely soluble in dichloromethane; Freely soluble in dichloromethane;
soluble in methanol; sparingly soluble in methanol; sparingly
soluble in ethanol (96%); soluble in ethanol (96%);
3. Identification
A. Melting range 148° to 152°C 1500 C
B. By IR The spectrum obtained due to the The spectrum obtained due to the
test should correlate with that of test correlates with that of same
same obtained due to the reference obtained due to the reference
spectrum. spectrum.
C. By TLC The principal spot in the The principal spot in the
chromatogram obtained with the chromatogram obtained with the
test solution is similar in position, test solution is similar in position,
colour and size to the principal spot colour and size to the principal
in the chromatogram obtained with spot in the chromatogram obtained
reference solution (a) with reference solution (a)
D. By chloride Gives the reaction (a) of chlorides Gives the reaction (a) of chlorides
4. Appearance of solution Solution S is clear and not more Solution S is clear and not more
intensely coloured than reference intensely coloured than reference
solution BY4 solution BY4
5. optical rotation -1.0 ° to + 1.0° -0.150
6. Related substance Total impurities:0.5% 0.094%
7. Sulfated Ash Not more than 0.1% w/w 0.08% w/w
8. Loss on drying Not more than 0.5% w/w 0.39 % w/w
9. Assay 98 .0 % w/w to 102.0% w/w(ODB) 98.61% w/w(ODB)

Conclusion: In the opinion of the undersigned given material complies/does not comply as per IP/BP/USP/IHS
specification.

Analysed By Checked By Approved By

Sign

Date
Format No.: YPR/QC/003/F08-00

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