Parameter | Limit | |
Appearance | : | White or almost white powder |
Identification (By HPLC) | : | The retention time of the principal peak in the chromatogram of the sample solution corresponds to that in the obtained chromatogram of the standard solution. |
Solubility | : | Slightly soluble in water and practically insoluble in methanol. |
Assay (HPLC, on dry basis) | : | 98 - 102 % |
Unspecified Impurities (HPLC) | : | NMT 1.0 % |
Total Impurities (HPLC) | : | NMT 3.0 % |
Water Content | : | NMT 6.0 % |
Specific Rotation (on dry basis) | : | - 19.00 to - 23.00 |
| CAS number | : | 147127-20-6 (anhydous); 107021-12-5 (racemic) |
