CAS number: 104344-23-2
Molecular formula: C22H35NO8
molecular weight: 441.52 g/mol
Chemical structure:
Sr No. | Test | Specification | Result | |
1 | Characters i. Appearance ii. Solubility | White or almost white, slightly hygroscopic powder. | White , slightly hygroscopic Powder. | |
Very soluble in water, freely soluble in methanol. | Conforms . | |||
2 | Identification | The IR abosorbtion spectrum should be concordant with that of Bisoprolol | Positive | |
3 | Related 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 | |
4 | Water By KF (%, w/w) | Not more than 0.5 | 0.2 | |
5 | Sulfated ash (%, w/w) | Not more than 0.1 | 0.04 | |
6 | Assay on anhydrous basis (%,w/w) | 99.0 to 101.0 | 99.89 | |
7 | Additional 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 |