Test |
|
Specification |
Characters |
: |
White or almost white, crystalline powder. |
Solubility |
: |
Practically insoluble in water, freely soluble in acetone, sparingly soluble in ethanol (96 per cent). |
Identification |
: |
Test – A, B & C |
Test – A |
: |
The Infra red absorption spectrum should be concordant with the spectrum obtained from std of Beclomethasone Dipropionate. |
Test – B |
: |
The solution gives the reaction (a) of chlorides. |
Test – C |
: |
Should complies with loss on drying test. |
Specific rotation |
: |
Between + 108.00 and + 115.000. |
Related substances |
: |
|
Impurity B,L |
: |
Not More Than 0.80% |
Impurity M |
: |
Not More Than 0.50% |
Impurity A, D |
: |
Not More Than 0.30% |
Impurity C |
: |
Not More Than 0.10% |
Unspecified Impurity |
: |
Not More Than 0.10% |
Total impurities |
: |
Not More Than 1.50 %. |
Loss on drying |
: |
Not more than 0.50%. |
Assay |
: |
96.00 to 102.00% w.r.t. dried substance. |
*In-house tests |
: |
(As per customer requirement) |
*Particle size |
: |
90.00% < 10 micron, 99.00% < 50 micron. |
End of specification |