| Customization: | Available |
|---|---|
| Application: | Surgery |
| Usage Mode: | For external use |
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| SPECIFICATION | ACCEPTANCE CRITERIA | RESULT |
| APPEARANCE | WHITE CRYSTALLINE POWDER | WHITE CRYTALLINE POWDER |
| IDENTIFICATION | PASS TEST | PASS TEST |
| STATE OF SOLUTION(T%) | NOT LESS THAN 98.0% | NOT LESS THAN 98.0% |
| SPECIFIC ROTATION (AT 20ºC) | -17.5 to -15.5ºC | -16.3ºC |
| AMMONIUM(NH4) | NOT MORE THAN 0.020% | NOT MORE THAN 0.020% |
| SULFATE(S04) | NOT MORE THAN 0.048% | NOT MORE THAN 0.048% |
| IRON(Fe) | NOT MORE THAN 10 ppm | NOT MORE THAN 10 ppm |
| HEAVY METALS(pb) | NOT MORE THAN 10ppm | NOT MORE THAN 10ppm |
| ARSENIC(As203) | NOT MORE THAN 1ppm | NOT MORE THAN 1ppm |
| RELATED SUBSTANCES(HPLC) | NOT MORE THAN 2.0% | NOT MORE THAN 2.0% |
| LOSS ON DRYING | NOT MORE THAN 0.50% | 0.15% |
| RESIDUE ON IGNITION | NOT MORE THAN 0.10% | 0.02% |
| ENDOTOXIN | LESS THAN 6.0 EU/g | LESS THAN 6.0 EU/g |
| ASSAY(DRY BASIS) | 98.0 to 101.0% | 99.3% |
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