Test |
|
Specification |
Characters |
: |
White to practically white, odourless powder.It should hygroscopic. |
Solubility |
: |
Freely soluble in water and in methanol; practically insoluble in acetone and in chloroform. |
Identification A (By IR) |
: |
The Infra red absorption spectrum should concordant with the spectrum obtained from working std of Betamethasone sodium phosphate or with the reference Infra red spectrum graph. |
Identification B (By TLC) |
: |
The Rf value of the principal spot in the chromatogram obtained from test solution should correspond to that obtained from working standard solution of Betamethasone sodium phosphate. |
Identification C |
: |
Residue of test sample should give the reaction of sodium salts and phosphates. |
Specific Rotation |
: |
+ 99.000 to + 105.000 on anhydrous basis. |
Water Content |
: |
Not more than 10.00%w/w. |
Limit of phosphate ions ( By UV ) |
: |
Not more than 1.00%w/w. |
Limit of Free Betamethasone ( By UV ) |
: |
Not more than 1.00%w/w. |
Residual solvents |
: |
Acetone not more than 5000.00 ppm.
Methanol not more than 3000.00 ppm.
Ethyl acetate not more than 5000.00 ppm.
Tetra hydro furan not more than 720 ppm.
|
Assay |
: |
Not less then 97.00 % w/w and not more then 103.00% w/w, on anhydrous basis. |
End of specification |