GMP API veterinary Tylosin tartrate 99% CAS NO.1405-54-5

Items

Standard

Results

Conclusion

Appearance

White to slightly yellow powder  

almost white powder  

Complies

Identification

It gives the positive reaction

It gives the positive reaction

Complies

It gives the positive reaction

It gives the positive reaction

Complies

The retention time of the tylosion A peak in the chromatogram of the test solution correspond to that in the chromatogram of the reference solution

The retention time of the tylosion A peak in the chromatogram of the test solution correspond to that in the chromatogram of the reference solution

Complies

It gives the positive reaction

It gives the positive reaction

Complies

Tests

pH

pH value 5.0-7.2

5.7

Complies

Tyramine

Complies

complies

Complies

Loss on drying

Not more than 4.2%

2.4%

Complies

Residue on ignition

Not more than 2.5%

0.23%

Complies

Heavy metals

Not more than20ppm

Less than 20ppm

Complies

Content of Tylosin

Tylosins A≥82%

89%

Complies

Tylosins A+B+C+D≥95%

97%

Complies

Assay

Assay(dried basis)

≥830u/mg(dried basis)

928u/mg(dried basis)

Complies

Assay(wet basis)

-

906u/mg(wet basis)

Complies

Conclusion:Tested according to in-house specification QS-0002-01,it complies with the requirements