Bisoprolol Fumarate

CAS number: 104344-23-2

Molecular formula: C22H35NO8

molecular weight: 441.52 g/mol

Chemical structure:

Sr No.TestSpecificationResult
1Characters
    i. Appearance
   
    ii. Solubility
White or almost white, slightly hygroscopic powder.White , slightly hygroscopic Powder.
Very soluble in water, freely soluble in   methanol. Conforms .
2IdentificationThe IR abosorbtion spectrum should be concordant with that of   BisoprololPositive
3Related substance by HPLC (%)
    i. Impurity G
    ii. Impurity A
    iii. Impurity E
    iv. Unspecified impurity
    v. Total impurity
Not more than 0.5
    Not more than 0.3
    Not more than 0.2
    Not more than 0.10
    Not more than 0.5
    Not more than 0.5
BDL
    0.27
    BDL
    0.07
    0.4
    0.2
4Water By KF (%, w/w)Not more than 0.50.2
5Sulfated ash (%, w/w)Not more than 0.10.04
6Assay on anhydrous basis (%,w/w)99.0 to 101.099.89
7Additional Test
    Residual solvent By GC-HS (ppm)
    i. Methanol
    ii. Methylene chloride
    iii. Acetone
Not more than 3000
    Not more than 600
    Not more than 5000
148
    BDL
    163