Product name:Gentamycin Sulphate BP2002/EP4 Sterile

Batch No.

1008156

Manufacturing date

Aug,2010

Reporting No.

156

Expire Date

Jul,2014

Packing

5 Bou/Tin,2 Tin/Cartion

Quantity

Sample

Analytical Results

Test item

Requirements

Results

Characters

A white or almost white powder,freely soluble in water,practically insoluble in alcohol and in ether

Complies

Identification

Tests according to monograph

Complies

Appearance of solution

Clear and not more intensely coloured than degree 6 of the range of Reference solutions of the most appropriate colour

Complies

PH

3.5 to 5.5

4.95

Specific optical rotation

+107° to  +121°

+115.7°

Methanol

Not more than 1.0 percent

Complies

Composition

C1             25.0 percent to 50.0 percent

30.09 percent

C1a            10.0 percent to 35.0 percent

31.46 percent

C2a +C2a       25.0 percent to 55.0 percent

38.45 percent

Water

Not more than 15.0 percent

10.06 percent

Sulphated ash

Not more than 1.0 percent

0.21 percent

Sulphate

32.0 to 35.0 percent

33.26 percent

Sterility

Complies with the test for sterility

Complies

Bacterial endotoxin

Not more than 1.67 IU./mg

Assay

Not less than 590 IU/mg(anhydrous substance)

(hydrous substance)

601 IU/mg

(anhydrous substance)

656 IU/mg

Conclusion

Complies with the standard of BP2002/EP4