Customization: | Available |
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Type: | Pharmaceutical Intermediate |
Chemical Character: | Nature |
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ITEM | SPECIFICATION | RESULT | METHOD |
Appearance | White powder, neutral odor, highly hygroscopic | Conforms | Visual |
Identification | Standard solution and test solution same spot,RF | Conforms | TLC |
Specific Optical | -2.4°~ -2.8° | -2.72° | |
Heavy metals (as PB) | ≤10ppm | Conforms | |
Sulfate (SO4) | ≤0.02% | Conforms | Colorimetry |
Chloride (Cl) | ≤0.02% | Conforms | Colorimetry |
Phosphate Ion (P) | ≤5ppm | Conforms | Colorimetry |
Residual solvent(ethanol) | ≤1.0% | Conforms | HS-GC |
pH | 4.5~7.0 | 5.10 | |
Related substance | Spot not bigger than standard solution spot | No spot | TLC |
Water Content | ≤2% | 0.26% | KF |
Assay (dried basis) | 98.0%--102.0% | 99.48% | Potentiometric titration |
Assay (dried basis) | 98.5%--100% | 99.2% | HPLC |