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PRODUCT NAME | ||
TEST ITEMS | SPECIFICATION | RESULTS |
Description | White Or Almost White Crystalline Powder | White Powder |
Identification | Infrared Absorption | Positive |
Assay | 97.0~103.0% | 99.2% |
Melting Point | 33~37ºC | 34.5~36.5ºC |
Loss On Drying | 0.5%max | 0.30% |
Organic Volatile Impurities | 2500PPm max | <1000PPm |
Residual Solvents | Meet the requirements.(USP29) | Confirms |
Chromatographic purity | sum of impurities:3.0%max | <3.0% |
Conclusion | The specification conform with USP32 standard |