Test |
|
Specification |
Characters |
: |
White to practically white, odourless, crystalline powder. It should melt at about 240.00C, with some decomposition. |
Solubility |
: |
Insoluble in water; sparingly soluble in acetone, in alcohol, in dioxin, and in methanol; very slightly soluble in chloroform and in ether. |
Identification A (By IR) |
: |
The Infra red absorption spectrum should concordant with the spectrum obtained from Betamethasone working standard. |
Identification B (By TLC) |
: |
The Rf value of the principal spot obtained from the test solution should correspond to that obtained from the standard solution. |
Specific rotation |
: |
Between + 118.000 to + 126.000 on dried basis. |
Loss on drying |
: |
Not more than 1.00%w/w. |
Residue on Ignition |
: |
Not more than 0.200%w/w. |
Ordinary Impurity ( By TLC ) |
: |
Not More than 2.00%. |
Residual solvents |
: |
Meets the requirements. |
Assay |
: |
97.00 % to 103.00% w/w, on dried basis. |
End of specification |