Betamethasone Dipropionate CAS5593-20-4
Test items |
Specifications |
Results |
Description |
|
Almost white crystalline powder |
Solubility |
Practically insoluble in water,freely soluble in acetone and in methylene chloride,sparingly soluble in ethanol |
Complies |
Identification(IR,TLC) |
Complies with the standard |
Complies |
Specific rotation(In dioxane) |
+63°~ +70° |
+66.4° |
Loss on dryling |
Not more than 1.0% |
0.11% |
Residue on ignition |
Not more than 0.2% |
0.05% |
Related substances (HPLC) | ||
-Single impurity |
Not more than 1.0% |
0.18% |
- Total impurities |
Not more than 2.0% |
0.58% |
Assay (HPLC,basis on drying) |
97.0%~103.0% |
100.6% |
Residual solvents | ||
Acetone |
Not more than 5000ppm |
Complies |
Methanol |
Not more than 3000ppm |
Complies |
Dichloromethane |
Not more than 600ppm |
Complies |
THF |
Not more than 720ppm |
Complies |
Pyridine |
Not more than 200ppm |
Complies |
Packaging and storage:Preserve in tight,light-resistant containers. | ||
Conclusion:The test product complies with the requirements of USP41. |