Product specification
| Parameter | Specification |
|---|---|
| Characteristics | White or almost white, crystalline powder. Practically insoluble in water, sparingly soluble in acetone and in ethanol (96%), slightly soluble in methylene chloride. It shows polymorphism. 97.0% - 103.0% (dried basis) Conforms to Ph. Eur. tests +162 o to +168 o Not more than 1.0% Not more than 0.5% (each) Not more than 0.4% Not more than 0.3% Not more than 0.2% (each) Not more than 0.15% (each) Not more than 0.10% (each) Not more than 2.0% Non-hazardous chemical Keep container tightly closed in a cool and dry place and protected from light. Protect from contamination by foreign substances. Hydrocortisone Acetate Ph. Eur. PRODUCT SPECIFICATION CHARACTERISTICS Assay (Content) Identification Specific rotation Loss on drying Impurity C (prednisolone acetate) Impurity A (hydrocortisone) Impurity B (oxenol) Impurity D (cortisone acetate) Impurity E Impurity G Unspecified impurities Total impurities HAZARDOUS IDENTIFICATION STORAGE White or almost white, crystalline powder. Practically insoluble in water, slightly soluble in anhydrous ethanol and in methylene chloride. 97.0% - 102.0% (dried basis) Conforms to Ph. Eur. tests +158 o |
| Assay (Content) | to +167 |
| Identification | o |
| Specific rotation | Not more than 0.5% |
| Loss on drying | Not more than 0.6% |
| Impurities C, D, E, I | Not more than 0.4% |
| Impurity G | Not more than 0.3% |
| Impurity F | Not more than 0.3% |
| Impurities A, B | Not more than 0.3% |
| Impurities H, N | Not more than 0.15% |
| Unspecified impurities | Not more than 0.10% |
| Total impurities | Not more than 1.0% |
| Hazardous Identification | Non-hazardous chemical |
| Storage | Keep container tightly closed in a cool and dry place and protected from light. Protect from contamination by foreign substances. |