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CERTIFICATE OF ANALYSIS

Product Name BISOPROLOL FUMARATE

Pharmacopeial Compliance Fh. Eur. A.R. No. FPt22t097
Batch No. BIF1XO2207 Date of Samnline 2U06t2022
Date of Mfe. Jun.2022 Date of Release 28t06t2022
Date of Retest May.2027 Dispatch Oty. 5.000 Ks
Specification No. 81003/DSStOt30 Revision No. 1.1

Sr. Test Specification Result

No.
White or almost white, slightly White,slightly hygroscopic
1 Appearance
hvsroscopic powder powder.
Very soluble in water, freely Very soluble in water,
2 Solubility soluble in methanol. It shows freely soluble in methanol.
polvmorphism. It shows polymorphism.
Identification
3 Infrared absorption Concordant with standard Concordant with standard
Spectrophotometry reference spectrum. reference spectrum.
Related Substances (by HPLC)
a) Impurity G a) Not more than 0.5% a) Not Detected
b) Impurity A b) Not more than 0.3% b) 0.16%
4
c) Impurity E c) Not more than 0.2%o c) Not Detected
d) Unspecifi ed Impurities d) Not more than 0.10% d) Less than 0.05%
e) Total Impurities e) Not more than 0.502 e\ 0.33%
5 Water Not more than0.5 o/o 0.25%
6 Sulphated ash Not more than}.l Yo 0.06%
Assay Ca6H66N2O12 99.0%to 101.0% 100.0%
7
(On Anhvdrous basis)
Residual Solvents
a) Acetone a) Not more than 5000 ppm a) 194 ppm
8 b) Methanol b) Not more than 3000 ppm b) 20ppm
c) Toluene c) Not more than 890 ppm c) 6ppm
d) Ethyl Acetate d) Not more than 5000 ppm d) 1 ppm

Remark: The Product meets the above specification of Bisoprolol Fumarate Ph. Eur., hence is of the
standard quality.

Prepared by Checked by Annroved by

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Format No. : SOP/QC/00f 0/40003-004 Page 1 of I

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