PLAVIX

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Jinan Hongfangde Pharmatech C o., Ltd

Business Type:Manufacturer

Country/Region:China

Ddu Verified

HOT Rank

6/10

Product Information

Description


PLAVIX;SR-25990C;CLOPIDOGREL SULFATE;CLOPIDOGREL SULPHATE;CLOPIDOGREL HYDROGEN SULPHATE;CLOPIDOGREL BISULPHATE;CLOPIDOGREL BISULFATE;Myogrel

120202-66-6

C16H16ClNO2S.H2O4S

419.9

CERTIFICATE OF ANALYSIS

 

Product Name

Clopidogrel  Bisulfate

Batch No.

20170405

Expiry Date

2020-05

Report Date

2017-04-15

Quantity

50Kg

 

Items

Standard

Results

Appearance

White or off-white powder

Comply

Identification

1IRThe IR   spectrum of sample recorded as KBr pellet is concordant with similarly   recorded spectrum of working standard.

Comply

2The retention time of the major peak in the chromatogram   of the Assay preparation   corresponds to that in the chromatogram of the Standard preparation,   as obtained in the Assay.

Comply

3It responds to the test for   Sulfate.

Comply

Solubility

  Freely soluble in methanol and   water,practically;insoluble in ether

Comply

Assay

97.0%-101.5%

99.5%

Related Substances

Impurity A

≤0.2%

0.06%

Impurity B

≤0.3%

0.19%

Impurity C

≤1.0%

N/D

Other single impurity

≤0.1%

0.01%

Total impurities

≤1.5%

0.28%

Loss on drying

≤0.5%

0.23%

Heavy metals

≤10ppm

Comply

Residue on ignition

≤0.1%

0.05%

Storage

Keep tightly closed in a   dry place. Protected from light with original package.

Determination

Complies with USP36

 



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