1 | Description | White powder. On exposure to light it gradually darkens. Melts at 190°C | White or slightly yellow crystals or powder. On exposure to light it gradually darkens. Melts at about 190°C |
2 | Solubility | Passes | Freely soluble in water; spairingly soluble in alcohol; insoluble in chloroform, in ether, and in benzene. |
3 | Identification A (By IR) | Complies | The IR spectra of the sample should be concomitant with the IR spectra of the corresponding standard. |
4 | Identification B (By chemical test) | Complies | The solution should reduce slowly at room temperature but not more readily upon heating. |
5 | Assay | 99.3% | 99.0% - 100.5% |
6 | Residue on ignition | 0.07% | 0.1% max. |
7 | Optical rotation : Specific rotation | +20.7° | +20.5° to +21.5° |
8 | Total aerobic microbial count | Less than 1000 CFU/g | NMT 1000 CFU/g |
9 | Total combined yeast and mold count | Less than 100 CFU/g | NMT 100 CFU/g |
10 | Bacterial endotoxins | Less than 1.2 EU/g | NMT 1.2 EU/g |