Jinan Hongfangde Pharmatech C o., Ltd
We are professional supplier of Entecavir monohydrate CAS209216-23-9,Terbinafin HCI CAS78628-80-5,Gadopentetic acid CAS80529-93-7,Gadopentetate monomeglumine CAS92923-57-4,Gadopentetate Dimegl
Business Type:Manufacturer
Country/Region:China
Ddu Verified
HOT Rank
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 | 1）IR：The IR spectrum of sample recorded as KBr pellet is concordant with similarly recorded spectrum of working standard. | Comply | |
2）The 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 | ||
3）It 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 | ||
