| Function: | Antineoplastic |
|---|---|
| Grade Standard: | Medicine Grade |
| Type: | Chemical Reagent |
| State: | Powder |
| Volatile: | Not Volatile |
| Standard: | in-House |
| Samples: |
|---|
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Audited Supplier | Items | Standard |
| Character | White or off-white powder |
| Loss on drying | ≤1..0% |
| Heavy Metals | ≤20ppm |
| Optical Rotation | -45°~-55° |
| Related substances | Unspecified impurity≤0.10% |
| Total impurities≤1.0% | |
| Residual solvents | Methanol≤0.3% |
| Dichloromethane≤0.06% | |
| Hexane≤0.029% | |
| Ethyl acetate≤0.5% | |
| Purity | ≥99.0% |
| Items | Standard |
| characters | |
| Appearance | White to off-white powder and block or crystalline powder |
| Specific Rotation | Specific rotation-50.5°~-54.5° |
| Identification | |
| UV Identify | Shall have the biggest at 270 nm wavelength absorption |
| IR Identift | IR Spectrum of the sample corresponds to that of tje Bortezomib RS |
| HPLC Identify | The retention time of the major peak of the Sample solution corresponds to that of the Standard solution,as obtained in the Assay |
| Chromogenic Reaction | Ignition residue should show the identification of boric acid salt (2) reaction |
| Acidity | The pH value should be 4.0~6.5 |
| Clarity and Color of The Methanol Solution | Solution should be clear colorless |
| Related Substances | |
| Impurity C | Not more than 0.2% |
| The Total of Impurity A and Impurity B | Not more than 0.4% |
| The Total of Impurity M and Impurity N | Not more than 0.4% |
| Diastereomer | Not more than 0.3% |
| Other Individual Impurity | Not more than 0.1% |
| The Total of Impurity | Not more than 1.5% |
| Enantiomorphism Isomers | Not more than 1.0% |
| Residual Solvents | |
| Meyhanil | Not more than 0.3% |
| Acetone | Not more than 0.5% |
| Methylene Chloride | Not more than 0.06% |
| Ethyl Acetate | Not more than 0.5% |
| n-heptane | Not more than 0.5% |
| DMF | Not more than 0.088% |
| Loss on Drying | Not more than 2.0% |
| Heavy Metal | Not more than 20 ppm |
| Microbial Limit | |
| TAMC | -NMT 100 cfu/g(ml) |
| TYMC | -NMT 10 cfu/g(ml) |
| Pseudomonas aeruginosa | Absent/g |
| Staphylococcus aureus | Absent in 1 g or 1 ml |
| Enterobacterias resistant to bile | Absent on 1g/ml |
| Bacterial Endotocins | Less than 16 EU/mg |
| Assay | Contain C57H69B3N12O9 shall not be less than 98.0%(on the dried basis) |
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