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Items |
Specifications |
Results |
Methods |
Assay (As Dried Base %) |
NLT98.5~101%% |
99.82% |
HPLC |
Appearance |
Crystalline Powder |
Complies |
Visual |
Identification |
Positive |
Complies |
IR&1H NMR |
Color |
White to Colorless |
Complies |
Visual |
Odor & Taste |
Characteristic |
Complies |
Organoleptic |
Loss on drying |
NMT1.00% |
0.28% |
USP |
Melting point |
97℃-98℃ |
97℃-98℃ |
USP |
Residue on ignition |
NMT 0.5% |
0.08% |
USP |
Total Heavy Metals |
NMT20ppm |
Complies |
USP |
Related substance |
Meet the requirements |
Complies |
USP |
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