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Bisoprolol Fumerate

Bisoprolol Fumerate
Bisoprolol Fumerate
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Product Code : 002
Brand Name : accurate pharaceutical
Product Description

Name of Product

BISOPROLOL FUMARATE EP


Batch No.

AP/BSF/1701


Date of Manufacturing

February 2017

A.R. No.

BSF-170201


Date of Expiry

January 2022

Batch Quantity

25.010 Kgs


Sr.No.

Tests

Specifications

Results


1

Description

White crystalline powder.

White powder.


2

Solubility

Very soluble in water and methanol, freely soluble in chloroform, glacial acetic acid and . Slightly soluble in acetone and ethyl acetate.

Complies

3

Identification by IR

A) I.R. Test.

Complies

4

Sulphated ash

Note more than 0.1%

0.06

5

Water content by KF

Note more than 0.5%

0.33 % w/w

6

Related Substances by HPLC

  1. Impurity G

  2. Impurity A

  3. Impurity E

  4. Any unspecifited Impurity

  5. Total Impurity



Not more then 0.5 %

Not more then 0.3 %

Not more then 0.2 %

Not more then 0.1 %

Not more then 0.5 %



0.080 %

0.078 %

0.032 %

0.071 %

0.261 %

7

Assay Potentiometry

(On anhydrous basis)


99.0% to 101.0 %


99.89 %


ACCURATE PHARMACEUTICALS
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