Test |
|
Specification |
Characters |
: |
White or almost white, crystalline powder. |
Solubility |
: |
Practically insoluble in water, freely soluble in acetone, sparingly soluble in ethanol (96 percent). |
Identification |
: |
The Infra red absorption spectrum should be concordant with reference spectrum of Clobetasol propionate CRS. |
Specific optical rotation |
: |
+112.00 to+118.00C on Dried basis. |
Related substances |
: |
Impurity E: Not more than 0.70% |
|
: |
Impurity D: Not More Than 0.50 % |
|
: |
Impurity B,C: Not More Than 0.30 % |
|
: |
Impurity A,L,M: Not More Than 0.20 % |
|
: |
Unspecified impurity: Not More Than 0.10 % |
|
: |
Total impurities: Not More Than 2.00%. |
Loss on drying |
: |
Not more than 0.50%w/w |
Sulphated Ash |
: |
Not more than 0.100%w/w |
Assay |
: |
97.00 to 102.00%.w.r.t dried substance. |
End of specification |