 Cephalexin Monohydrate
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PRODUCT SPECIFICATION |
This product is analysed and certified as per in house specifications: |
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TESTS |
SPECIFICATION |
| Description | White to almost white crystalline powder |
| Solubility | To Conforms |
| Identification 1 By IR | To Conforms |
| Identification 2 By HPLC | To Conforms |
| pH | 4.0 to 5.5 |
| N N Dimethylaniline | NMT 20 ppm |
| Specific rotation | +149° to +158° |
| Limit Absorption | To Conforms |
| Water Content | 4.0 to 8.0 %w/w |
| Sulphated Ash | NMT 0.2 %w/w |
| Related Substances | In House Specification 7-ADCA:-NMT 0.5% Phenyl glycine:-NMT 0.5% Any other Impurity:-NTM 0.5% |
| Assay (OAB) (%w/w) (By HPLC) | NLT 95.0% w/w to 101.0 %w/w |
| Bulk Density | 0.75 g/ml-0.85 g/ml |