Bisoprolol Fumarate (EP/USP)

We are offering 22 tests specifications
1 characteristics white crystalline powder
2 solubility very soluble in water and in methanol. Freely soluble in chloroform, in glacial acetic acid and in alcohol slightly soluble in acetone and in ethyl acetate.
3 identification by by ir
the rt of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation, as obtained in the assay.
4 specific rotation between - 2 0 & + 20
5 water not more than 0.5%
6 residue of lgnition not more than 0.10%
7 heavy metals not more than 0.002 ppm
8 chromatographic purity not more than 0.5% of total impurity
9 fumaric acid (on anhydrous basis) 14.8 % to 15.04%
10 assay (by hpcl) 97.5% - 102%
11 residual solvent by gc
a)dichloromethane
b)ethyl acetate
c) acetone
not more than 600 ppm.
not more than 5.000 ppm
not more than 5.000 ppm