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Bacitracin Zinc

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  • USP, EP

Bacitracin Zinc

CAS number1405-89-6

Molecular formulaC66H101N17O16SZn

molecular weight1486.07

Packing: 25kg/drum

Valid time: 3years

Specification:

ITEM

SPECIFICATION

RESULT

Appearance

White or light yellowish-grey, hygroscopic powder

conform

Identification

Test B: HPLC

Conform

Conform

Test C: Zinc

Conform

Conform

PH

6.0-7.5

6.55

Loss on drying

≤5.0%

4.0%

Zinc(dried substance)

3.5%-5.5%

5.1%

Content(dried substance)

≥60 IU/mg

71 IU/mg

Composition

Bacitracin A ≥45.0%

58.1%

Sum of Bacitracins A, B1, B2 and B3≥77.0%

81.9%

Related substances

Sum of impurities L and N: ≤8.0%

4.6%

Impurity E: ≤4.0%

3.0%

Impurity A: ≤3.5%

0.7%

Impurity B: ≤3.0%

0.9%

Impurity M: ≤3.0%

1.2%

Impurity C: ≤2.5%

1.1%

Sum of impurities O, Pand Q: ≤2.5%

2.1%

Sum of impurities F, Pand G: ≤2.5%

1.0%

Impurity H: ≤1.0%

0.6%

Any other impurity: for each impurity ≤2.0%

0.9%

Total:  ≤23.0%

18.3%

Reporting threshold: >0.25%

RRT0.59: 0.42%

RRT0.62: 0.81%

RRT0.76: 0.36%

RRT1.49: 0.28%

Conclusion:

The product meets EP 9.1


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