Test |
|
Specification |
Description |
: |
White to cream, crystalline powder. |
Solubility |
: |
Practically insoluble in water; slightly soluble in benzene and in diethyl ether: sparingly soluble in ethanol; soluble in acetone, in dimethyl sulfoxide, in chloroform, in methanol, and in dioxane. |
Identification – A |
: |
The Infra red absorption spectrum should be concordant with the spectrum obtained from std of Clobetasol propionate. |
Melting range |
: |
Approximately 196.0 0C. |
Specific rotation |
: |
Between + 98.00 and + 104.000. |
Loss on drying |
: |
Not more than 2.00%. |
Residue on ignition |
: |
Not more than 0.100%. |
Heavy metals |
: |
20 μg per g. (Not more than 20 ppm) |
Chromatographic purity |
: |
Any Individual impurity should not more than 1.00%. |
|
: |
Total impurities should not more than 2.50%. |
Residual solvents |
: |
Methanol not more than 3000.00 ppm. |
|
: |
Acetone not more than 5000.00 ppm. |
Residual solvents |
: |
Methylene Chloride not more than 600.00 ppm |
|
: |
Ethyl acetate not more than 5000.00 ppm. |
|
: |
Chloroform not more than 60.00 ppm |
|
: |
Pyridine not more than 200.00 ppm. |
|
: |
Dimethylformamide not more than 880.00 ppm. |
Assay |
: |
97.00 to 102.00% w.r.t. dried substance. |
*In-house tests |
: |
(As per customer requirement) |
*Light Absorption |
: |
NMT 0.075 abs. (5% w/v solution in dioxane, Read at 430 nm) |
*Microbial limits |
: |
Total Microbial counts 100 cfu/g |
|
: |
Absence of Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella species. |
*Particle size |
: |
90% < 20 micron; 100% < 50 micron. |
End of specification |