| Function: | Anticoagulants |
|---|---|
| Grade Standard: | Medicine Grade |
| Type: | Chemical Reagent |
| State: | Powder |
| Volatile: | Not Volatile |
| Shelf Life: | 2 Years |
| Samples: |
|---|
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Audited Supplier | Items | Standard | Results | |
| Appearance | White or almost white powder | Almost white powder | |
| Identification | A.Corresponds to IR Spectrum of reference substance(EP 2.2.24) | Conforms | |
| B.Enantiomeric purity(HPLC,EP2.2.29) | Conforms | ||
| C.It gives reaction (a) of sulfate(EP2.3.1) | Conforms | ||
| Appearance of solution | Clear (EP2.2.1) and not more intensely coloured than reference solution Y6(EP2.2.2,method I) | Conforms | |
| Specific optical rotation (EP2.2.7) | +54.0°~+58.0° | +56.9° | |
| Enantiomeric purity (HPLC,EP2.2.29) | Impurity C≤0.5% | 0.03% | |
| Water(EP2.5.12) | ≤0.5% | 0.11% | |
| Sulfated ash(EP2.4.14) | ≤0.1% | 0.04% | |
| Heavy metals(EP2.4.8) | ≤20ppm | <20ppm | |
| Related compounds (HPLC,EP2.2.29) | Impurity A≤0.2% | 0.004% | |
| Impurity B≤0.3% | 0.02% | ||
| Unspecified impurities≤0.10% | ND | ||
| Total impurities≤0.5% | 0.03% | ||
| Assay(EP2.2.20) | 99.0%~101.0%C16H16CINO2S•H2SO4,calculated on anhydrous substance. | 99.4% | |
| Additional items(In-house) | |||
| Formaldehyde (EP2.2.25) | ≤10ppm | 1.19ppm | |
| Residual solvents (GC,EP2.2.28) |
Methanol ≤0.3% | 0.0078% | |
| Acetone ≤0.5% | 0.1432% | ||
| Methylene chloride ≤0.06% | ND | ||
| Isopropyl alcohol ≤0.5% | 0.0250% | ||
| Ethyl acetate ≤0.5% | ND | ||
| Toluene ≤0.089% | ND | ||
| Packaging and storage:keep in an air-tight container,protected form light. | |||
| Conclusion:All the results conform to the requirement of EP9.0 and In-house. | |||
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