| Function: | Antineoplastic |
|---|---|
| Certification: | GMP |
| Grade Standard: | Medicine Grade |
| Type: | Chemical Reagent |
| State: | Powder |
| Volatile: | Not Volatile |
| Samples: |
|---|
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Audited Supplier | Certificate of Analysis | ||||
| Product Name | Oxaliplatin | Manufacture date | 2020.09.28 | |
| Specification basis | EP9.8 | Retest date | 2023.09.27 | |
| Items | Standard | Results | ||
| Appearance | White or almost white,crystalline powder | White crystalline powder | ||
| Solubility | Slightly soluble in water,very slightly soluble in methanol,practically insoluble in anhydrous ethanol | conforms | ||
| Identification | A:The infrared absorption spectrum of the substance should correspond to the spectrum of oxaliplatin reference substance | conforms | ||
| B:Specific optical rotation:+74.5° to +78.0°(dried substance) | +76.1° | |||
| Appearance of solution 1 | Clear | Clear | ||
| Appearance of solution 2 | Colourless | Colourless | ||
| Acidity | Not more than 0.60ML of 0.01M sodium hydroxide is required | 0.54ml | ||
| Specific optical rotation | +74.5° to +78.0°(dried substance) | +76.1° | ||
| Related substances(HPLC) | Impurity A:not more than 0.10% | 0.002% | ||
| Impurity B:not more than 0.10% | 0.01% | |||
| Impurity E:not more than 0.10% | ND | |||
| Impurity C:not more than 0.10% | 0.001% | |||
| Unspecified impurity:not more than 0.10% | LTDL | |||
| Sum of unspecified impurities:not more than 0.10% | LTDL | |||
| Sum of impurities(other than impurity D):maximum 0.30% | 0.01% | |||
| Impurity D(HPLC) | Not more than 0.10% | 0.01% | ||
| Silver(AAS) | Maximum 5.0ppm | 0.05ppm | ||
| Loss on drying | Maximum 0.5 percent | 0.06% | ||
| Bacterial endotoxins | Less than 1.0 IU/mg | Conforms | ||
| Assay(HPLC) | Contains 98.0 percent to 102.0 percent of oxaliplatin(C8H14N2O4Pt),calculated on the dried substance | 99.9% | ||
| Chlorides | Not more than 100 ppm | Below the limit | ||
| Chloride content(IC) | Not more than 100 ppm | 0.62ppm | ||
| Microbial limits | Total aerobic microbial count:not exceed 100 cfu/g | <1cfu/g | ||
| Total yeasts and moulds count:not exceed 100 cfu/g | <1 cfu/g | |||
| Escherichia coli:should be absent/g | Absent | |||
| Staphylococcus aureus:should be absent/g | Absent | |||
| P.aeruginosa:should be absent/g | Absent | |||
| Conclusion | conform | |||
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