| Function: | Muscle Relaxants |
|---|---|
| Certification: | GMP |
| Grade Standard: | Medicine Grade |
| Type: | API |
| State: | Solid |
| Volatile: | Not Volatile |
| Samples: |
|---|
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Audited Supplier | Items | Standards | Results |
| Appearance | Off-white to light yellow powder,hygroscopicity | Off-white powder, hygroscopicity |
| Solubility | Freely soluble in water,ethanol trichloromethane or glacial acetic acid,almost insoluble in ether | complied |
| Specific rotation | +28.5°to+32.0° | +30.9° |
| Identification | ||
| (1) | The retention time of test solution main peak should be accordance with system suitability test solution of Rocuronium Bromide peak. | complied |
| (2) | Identification reaction of bromide in aqueous solution of this product | complied |
| (3) | The infrared absorption of this product should be accordance with W.S spectrum | complied |
| Alkalinity | PH:8.9-9.5 | 9.3 |
| Color and clarity of solution | The solution should be colorless and clarified;If it appears color,should not be stronger than yellow or orange yellow No.2 standard colorimetric solution. | complied |
| Acetic acid | Not more than 0.5% | N.D |
| 3-Bromopropene | If there are chromatographic peaks with the same retention time as the main peak of the control solution,the peak area should not more than the main peak area of the reference solution(0.0005%) | N.D |
Related substances |
Impurity A not more than 0.1% | N.D |
| Impurity B not more than 0.2% | 0.06% | |
| Impurity C not more than 0.2% | 0.01% | |
| Impurity F not more than 0.1% | 0.01% | |
| Impurity G not more than 0.1% | N.D | |
| Impurity H not more than 0.1% | N.D | |
| Other single impurity not more than 0.10% | N.D | |
| Total impurities should be not more than 1.0% | 0.087% | |
| Residual solvents | Methanol not more than 0.3% | N.D |
| Ethyl ether not more than 0.5% | 0.2% | |
| Acetone not more than 0.5% | 0.004% | |
| Acetonitrile not more than 0.041% | N.D | |
| Dichloromethane not more than 0.06% | N.D | |
| Methyl tert-butyl ether not more than 0.5% | 0.02% | |
| Triethylamine | Not more than 0.032% | N.D |
| Water content | Not more than 3.5% | 1.8% |
| Residue on ignition | Not more than 0.1% | 0.06% |
| Heavy metal | Not more than 10ppm | complied |
| Bacterial endotoxin | Endotoxin amount per 1mg Rocuronium Bromide should be less than 0.3EU | complied |
| Assay(calculate by anhydrous&solvent-free substances) | 99.0%-101.0% | 100.7% |
| Conclusion | This product is tested by Rocuronium Bromide(For export)quality standard(STP-11-338-01). The results comply with(√Yes No). The results comply with EP10.0 Rocuronium Bromide quality standard. |
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