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. |