Function: | Anticoagulants |
---|---|
Grade Standard: | Medicine Grade |
Type: | Chemical Reagent |
State: | Powder |
Volatile: | Not Volatile |
Shelf Life: | 2 Years |
Samples: |
---|
Suppliers with verified business licenses
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. |
Suppliers with verified business licenses