| Powder: | Yes |
|---|---|
| Customized: | Customized |
| Certification: | GMP, HSE, ISO 9001, USP, BP |
| Suitable for: | Elderly, Children, Adult |
| State: | Powder |
| Purity: | >99% |
| Samples: |
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| Customization: |
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| Items | Specifications | Results |
| Appearance | White or almost white, crystalline powder | White, crystalline powder |
| Identification | ||
| A: IR | The positions and the relative sizes of the bands in the spectrum of the sample are concordant with those in the spectrum of the reference standard. | Conforms |
| B: Specific optical rotation | It complies with the test for specific optical rotation. | Conforms |
| Tests | ||
| Appearance of solution | Clear and colourless | Conforms |
| Acidity | Not more than 0.60ml of 0.01M NaOH is required to change the color of the indicator to pink | 0.36ml |
| Specific optical rotation | +74.5 to +78.0 | +76.4 |
| Impurity D | Not more than 0.15% | 0.072% |
| Related substances: | ||
| Impurity A | Not more than 0.15% | 0.022% |
| Impurity B | Not more than 0.15% | 0.035% |
| Impurity C | Not more than 0.15% | 0.0084% |
| Unspecified impurities | Not more than 0.10% | Undetected |
| Sum of unspecified impurities | Not more than 0.15% | Undetected |
| Sum of impurities other than D | Not more than 0.30% | 0.065% |
| Silver | Max 5ppm | 1.0ppm |
| Loss on drying | Max 0.5% | 0.06% |
| Bacterial endotoxins | Less than 1.0IU/mg | 1.0IU/mg |
| Assay | 98.0%~102.0% | 100.2% |
| Microbial limits | ||
| Total aerobic bacteria count | Not more than 2000cfu/g | 100cfu/g |
| Total combined yeast and molds count | Not more than 200cfu/g | 100cfu/g |
| Search phtaogens | ||
| E. coli | Should be absent in 1g of Oxaliplation | Undetected |
| Salmonella spp | Should be absent in 1g of Oxaliplation | Undetected |
| P. aeruginosa | Should be absent in 1g of Oxaliplation | Undetected |
| S. aureus | Should be absent in 1g of Oxaliplation | Undetected |
| Conclusion: the batch conforms to the specification of Oxaliplatin in current PH. Eur. | ||
| Shipping Terms | ||
| By Express | By Air | By Sea |
| Suitable for under 50kg Fast:3-4 days High cost Door to door service Easy to pick up the goods |
Suitable for more than 50kg Fast:3-4 days High cost Airport to airport Professional broker needed |
Suitable for more than 500kg Slow:15-30 days Low cost Port to port Professional broker needed |
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