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Items of Analysis | Standard of Analysis | Test Results |
Appearance | White crystalline powder | White crystalline powder |
Identification | IR | Complies with Std |
Heavy Metals | ≤ 20ppm | ﹤20 ppm |
Melting Range | 143℃-148℃ | 146℃ |
Water | ≤ 0.5% | 0.22% |
Residue on ignition | ≤ 0.1% | 0.020% |
Impurity(TLC) | ≤ 1% | Complies with USP |
Assay (HPLC) | 98-102% | 99.94% |
Residual solvent | Hexane ≤ 290ppm Toluene ≤ 890ppm Methano ≤ 3000ppm |
Not Detected Not Detected Not Detected |
Conclusion | Conforms to Factory Standard |
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