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Items |
Standard |
Result |
Appearance |
White to off-white powder |
Conform |
Identification |
A. IR B. HPLC |
Conform Conform |
Melting point |
About 220℃ |
221.4℃ |
Specific rotation |
+56°~ +62° |
59.5° |
Loss on drying |
0.5% max |
0.19% |
Residue on ignition |
0.1% max |
0.07% |
Heavy metals |
30ppm max |
Conform |
Chromatographic purity |
Single impurity 1.0% max Total impurities 2.0% max |
Conform |
Assay |
97.0~102.0% |
99.45% |
Particle size |
90%<50μm |
Conform |
Conclusion |
Conform with USP35 |
CAS NO:29122-68-7
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CAS NO:29122-68-7
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