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Member Since 7 Years
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GST No. 24CHGPK8849A1ZCAsk for more detail from the seller
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| Items | Acceptable criteria | Results |
|---|---|---|
| Characteristics | A white or almost white powder | A white powder |
| Solubility | Practically insoluble in water: freely soluble in methylene chloride; Sparingly soluble in acetone(96%); slightly soluble in alcohol (96%) | Conforms |
| M.P | 162-166°C | 164.0-164.5°C |
| Identification | Conform to the spectrum of the CRS Gliclazide | Conforms |
| Heavy metals | ≤10ppm | <10ppm |
| Impurity B | ≤2ppm | 0.3ppm |
| Related substances | Impurity F ≤0.10% | <0.10% |
| Other single impurity ≤0.10% | <0.10% | |
| Total of other impurities ≤0.2% | 0.13% | |
| Loss on drying | ≤0.25% | 0.10% |
| Sulphated ash | ≤0.1% | 0.01% |
| Residual solvents | Ethyl acetate ≤0.5% | Below LOQ |
| Toluene ≤0.089% | Below LOQ | |
| Assay (on dried basis) | 99.0%-101.0% | 99.50% |
Conclusion : The test results conform with IP/BP
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