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Audited Supplier | Product Name | creatine phosphate sodium injection grade |
Batch Quantity | 200KGS |
| producing | Oct,30,2020 | Expiry Date | Oct,29,2022 |
| Batch No. | 20201030 | Certificate Completed | All |
| Standard | National Drug Standard Issued by SFDA: WS1-XG-029-2015 | ||
| Items | Specification (BP2015) | Results |
| Characters | White or almost white powder or crystalline powder | White crystalline powder |
| identification | Positive reaction | Positive reaction |
| HPLC | Renten time of major peak of assay preparation corresponds to rention time of reference preparation | conform |
| Sodium salt identification | Flame should be bright yellow | conform |
| PH value | 8---9 | 8.4 |
| Colour and clarity of solution | Should be clarity and colorless | conform |
| water | Should be 20-25.0% | 23.6% |
| Appearance of solution | Clear,odourless | conforms |
| Visible particles | Should comply | Conforms |
| Infusibility particulate | NMT 6000 particle of 10μm NMT 600 particle of 25μm |
Conform conform |
| sterile | Should comply | comply |
| Bacterial endotoxin | Should be less than0.15EU per mg | complies |
| Undue toxicity | Should comply | comply |
| Related Substances | Containing of creatine NMT 0.75% Containing of creatinine NMT 0.75% The peak area of any single unknow impurity should be less than the major peak area 0.5% The total impurity should be less than 2.0% |
0.032% 0.0023% 0.03% 0.064% |
| Heavy metals | ≤10ppm | conform |
| assay | Contains 90-110% percent of the labeled amount of creatine phosphate sodium | 99.5% |
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