Listing ID #3560414
Company Information
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Contact SupplierWe are sprawling over a large area with exceptional warehouse, which is well-equipped with cutting-edge technology and up-to-date management systems. With automated warehouse systems, we efficiently serve the bulk requirements. We believe in providing quality-approved products to the clients. For this, we make sure that all the inputs are procured from certified vendors after complete analysis of the quality.
Test Parameter | Specifications |
---|---|
Description | White to off-white powder |
Solubility | Freely soluble in any acid, practically insoluble in water. |
Identification | |
a) By IR | The infra-red absorbance spectrum obtained from the sample should be concordant with spectrum obtained with that Clopidogrel bisulfate RS/WS. |
b) By HPLC | The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay. |
c) Sulphate test | Should meet test for Sulfate |
Loss on drying (%w/w) | Not more than 0.5 |
Residue on ignition (%w/w) | Not more than 0.1 |
Assay by HPLC (% on dried basis) | Not less than 97.0 and not more than 101.5 |
Related substances by HPLC (%) | |
Clopidogrel Related Compound A | Not more than 0.2 |
Clopidogrel Related Compound B | Not more than 0.3 |
Individual impurity | Not more than 0.10 |
Total impurities | Not more than 0.5 |
Clopidogrel Related Compound C | Not more than 0.5 |
Residual Solvents by GC (ppm) | |
Methanol | Not more than 3000 |
Acetone | Not more than 5000 |
Isopropyl Alcohol | Not more than 5000 |
Methylenedichloride | Not more than 600 |
n-Hexane | Not more than 290 |
Ethyl acetate | Not more than 5000 |
Toluene | Not more than 890 |