USP, EP
Bacitracin Zinc
CAS number:1405-89-6
Molecular formula:C66H101N17O16SZn
molecular weight:1486.07
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 |
Bacitracin Zinc
CAS number:1405-89-6
Molecular formula:C66H101N17O16SZn
molecular weight:1486.07
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 |