Product Name:Gentamycin Sulfate BP2002/EP4.0

Batch No

20200320

Manufacturing Date

2020.03.20

Reporting No

20200320

Expiry Date

2024.03.19

Analytical Results

Items

Specifications

Results

Charaters

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

complies

Indentification

Positive reaction

complies

Appearance of solution

Clear and nor more intensely colored than degree 6 of the range of reference solusion of the most appropriate color.

complies

Acidity (PH)

3.5 to 5.5

4.9

Specific optical rotation

+107° to +121°

+118°

Methanol

Not more than 1.0 percent

complies

Composition

C1 25.0 to 50.0 percent

27.2%

C1a 10.0 to 35.0 percent

21.7%

C2a+C2 25.0 to 55.0 percent

51.2%

Water

Not more than 15.0 percent

10.7%

Sulphate Ash

Not more than 1.0 percent

0.2%

Sulphate

32.0 to 35.0 percent

32.7%

Bacterial endotoxins

Less than 0.71 IU/mg

complies

Assay

Not less than 590IU/mg(anhydrous substance)

690IU/mg

(anhydrous substance)

616IU/mg

Conclusion:Complies with the standard of BP2002/EP4.0.