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Test Items Specification Test Results Description White or off-white crystalline powder Off-white crystalline powder Specific rotation -56°~-60° -58.2° Identification IR Matches with working standard Complies HPLC Solubility Freely soluble in chloroform and in alcohol; Very slightly soluble in water Conform Heavy metals ≤10ppm <10ppm Water ≤0.3% 0.22% Residue on ignition ≤0.1% 0.05% Relative material Maximum impurities≤0.5% 0.36% Total impurities≤1.0% 0.52% Assay 98.5~101.0% 99.68% Conclusion The specification conform with USP29