Sr. No. | Test | Specification |
1 | Description | A white or almost white, crystalline powder. |
2 | Solubility | Slightly soluble in ethanol (95 percent) and in Dichloromethane , practically insoluble in water. |
3 | Identification | By IR : The Infra-red absorption spectrum of sample is concordant with that of the standard. |
4 | Specific optical rotation | Between +128°C to + 137°C (dried substance) |
5 | Loss on Drying | NMT 0.5 % |
6 | Related Substances | Impurity – A : NMT 1.0% Impurity – B : NMT 1.0% Impurity – C : NMT 1.0% Single Impurity –: NMT 0.1 % Total Impurity – : NMT 2.0% |
7 | Assay by UV | NLT 97.0% and NMT 103.0% of C23H30O6 (on dried Basis) |