| Product Name | Cefalexin Powder | |
| Shelf Life | 2 years | |
| Tests | BP2012 Specifications | Observations |
| Appearance | White or almost white, crystalline powder |
Almost white crystalline powder |
| Solubility | Sparingly soluble in water,practically insoluble in ethanol(96%) | Conform |
| Identification | IR spectrum should be concordant with the standard | Conform |
| PH | 4.0 to 5.5 | 4.9 |
| Specific optical rotation | +149° to +158°(anhydrous substance) | +155° |
| Related substances | ||
| Impurity B: | Not more than 1.0%(compared to the area of the 2nd peak) | <1.0% |
| Any other impurity: | Not more than 1.0%(compared to the area of the 1nd peak) | <1.0% |
| Total impurity: | Not more than 3.0% | <3.0% |
| N,N-Dimethylaniline | Maximum 20 ppm | Not used in process |
| Water | 4.0%to 8.0%,determined on 0.300 g. | 6.1% |
| Sulphated ash | Maximum 0.2%, determined on 1.0 g. | <0.1% |
| Assay | 95.0% to 102.0% of C16H17N3O4S (anhydrous substance) | 99.5% |
| Density | 0.27g/ml | |
| Remark:The product complies as per above BP2012 specifications. | ||