CAS No:61825-94-3
Shelf life:3 years
The detailed specifications are as below:
| Items | Standard |
| Appearance | White or almost white,crystalline powder |
| Solubility | Slightly soluble in water,very slightly soluble in methanol,practically insoluble in anhydrous ethanol |
| Identification | A:The infrared absorption spectrum of the substance should correspond to the spectrum of oxaliplatin reference substance |
| B:Specific optical rotation:+74.5° to +78.0°(dried substance) | |
| Appearance of solution 1 | Clear |
| Appearance of solution 2 | Colourless |
| Acidity | Not more than 0.60ML of 0.01M sodium hydroxide is required |
| Specific optical rotation | +74.5° to +78.0°(dried substance) |
| Related substances(HPLC) | Impurity A:not more than 0.10% |
| Impurity B:not more than 0.10% | |
| Impurity E:not more than 0.10% | |
| Impurity C:not more than 0.10% | |
| Unspecified impurity:not more than 0.10% | |
| Sum of unspecified impurities:not more than 0.10% | |
| Sum of impurities(other than impurity D):maximum 0.30% | |
| Impurity D(HPLC) | Not more than 0.10% |
| Silver(AAS) | Maximum 5.0ppm |
| Loss on drying | Maximum 0.5 percent |
| Bacterial endotoxins | Less than 1.0 IU/mg |
| Assay(HPLC) | Contains 98.0 percent to 102.0 percent of oxaliplatin(C8H14N2O4Pt),calculated on the dried substance |
| Chlorides | Not more than 100 ppm |
| Chloride content(IC) | Not more than 100 ppm |
| Microbial limits | Total aerobic microbial count:not exceed 100 cfu/g |
| Total yeasts and moulds count:not exceed 100 cfu/g | |
| Escherichia coli:should be absent/g | |
| Staphylococcus aureus:should be absent/g | |
| P.aeruginosa:should be absent/g |