双羟萘酸噻嘧啶22204-24-6质检单
Certificate of Analysis
Test No:C2307310501
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Product:Pyrantel Pamoate |
Package Size:20.0kg/barrel |
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Quantity:502.42 |
Date of Analysis:2023-07-24 |
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Batch No:2307001 |
Date of Report:2023-07-31 |
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Retest Date:2026-07-23 |
Manufacture Date:2023-07-24 |
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Specification:02TE0128 |
Batch Size:502.5kg |
Test results:
Tests Acceptance Limits est Result
Description ellow to tan solid Yellow solid
Identification
A.IR The IR spectrum of the Sample agrees with The IR spectrum of the Sample
R spectrum of the Standard agrees with spectrum of theStandard
B..UV The UV spectrum of the Sample agrees with The UV spectrum of the Sample
UV spectrum of the Standard agrees with UV spectrum of theStandard
C.HPLC The retention time of the major peaks due to The retention time of the major
Pyrantel base and pamoic acid of the peaks due to pyrantel base and
Sample solution correspond to the Standard pamoic acid of the Sample
Solution,as obtained in the Assay solution correspond to the Standard
solution ,as obtained in the Assay
Assay 97.0%~103.0%(dried basis) 99.7%
Pamoic acid 63.4%~67.3%(dried basisi) 64.9%
Limit of lron Not more than 0.0075% Less than 0.0075%
Residue on lgnition Not more than 0.5% 0.06%
Heavy Metals Not more than 50PPM Less than 50ppm
Organic Impurities
Pyrantel Related Not more than 0.5% Not detected
Compound A
Impurity B Not more than 0.2% Not detected
Individual Unspecified Not more than 0.1% 0.07%
Impurities
Total Unspecified Not more than 0.3% 0.07%
Impurities
Total impurities Not more than1.0% 0.07%
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Conclusion:Meet requirements of the SOP 02TE0128（USP36） |
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Remarks： |
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Approved by:ZHUJIA Reviewed by:CHUYANG Analyzed by:MOTIAN |
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