Gentamycin Solution CAS NO.1405-41-0

ITEMS

SPECIFICATIONS

RESULTS

Character 

White or almost white, hygroscopic powder

White ,hygroscopic powder

Identification 

Corresponding to reference spectrum 

Appearance of solution 

Clear and not more intensely colored than 

intensely 6 of the range of reference 

solutions of the most appropriate color  

Complies

pH

3.5--5.5

5.0

Specific optical rotation 

(anhydrous substance)

+107º to +121º

+120º

Methanol 

Max 1.0%

Not tested

Composition 

C1:20.0%--40.0%

26.7

C1a:10.0%--30.0%

27.6%

C2+C2a+C2b:40%--60.0%

45.7%

Related substance 

Any impurity  Max 3.0%

1.7%

Total  Max 10.0%

3.1%

Water 

Max 15.0%

8.0%

Sulphated ash 

Max 1.0%

0.2%

Sulphate (anhydrous substance)

32.0%--35.0%

33.8%

Bacterial endotoxins

Less than 0.71IU/mg

<0.50IU/mg

Assay (anhydrous substance)

Minimum 590IU/mg

661IU/mg

Conclusion 

This batch product complies with European Pharmacopoeia 6.0 specification.

Remark 

Methanol is not used during the production.