ITEMS OF TEST STANDARD RESULTS OF ANALYSIS Method Appearance White to almost white crystalline White crystalline hygroscopic In-house hygroscopic powder powder
Identification A: IR absorption Conforms USP42 B: Thin-layer chromatographic Conforms USP42 identification test
Loss of drying NMT 1.0% 0.28% Method<731> Melting range 64 ℃ -168 ℃ 164.7-165.7℃ Method<741> Heavy metals NMT 20ppm <20ppm MethodII<231> Residue on ignition NMT 0.1% 0.04% Method<281> Ph 4~6 4.9 Method<791> Chromatographic purity Total impurities: NMT2.0% Conforms USP42
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