PRODUCT NAME | Carbamazepine | |
Item | Specification | Results |
Appearance | White or almost white, crystalline powder | Conforms |
Solubility | very slightly soluble in water ,freely soluble in methylene chloride, sparingly soluble in acetone and in ethanol (96%) | Conforms |
Identification | (1) Melting Point : 189-193
(2) IR: very slightly soluble in water ,freely soluble in methylene Chloride, sparingly soluble in acetone and in ethanol (96%) |
Conforms |
PH | Positive | Conforms |
Related substances
(BY HPLC) |
Impurity :Not More than 0.1%
Impurity :Not More than 0.1% Unspecified impurities :Not More than 0.1% Total impurities : Not more than 0.5% Disregard limit :Not more than 0.05% |
Conforms
Conforms Conforms 0.31% Conforms |
Heavy metals | <20ppm | Conforms |
Loss on drying | <0.5% | 0.3 % |
Sulphated ash | <0.1% | 0.02% |
Chlorides | <140ppm | Conforms |
Assay
(on dried substance) |
98.0% ~ 102.0% | 100.4% |
Conclusion | It Conforms to BP2010 standards. |
Packaging details:
Packaging details: | 25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
Storage: | Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
Shelf Life: | 5 years if sealed and store away from direct sun light. |
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