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Test items Standard 1. Description White to off white crystalline powder a. Melting point **5~**9c b. Specific rotation **7~ **2° 2. Identification a. Chemical reaction Meet the requirement b. (HPLC) Meet the requirement c. IR Meet the requirement 3. Related substances Single impurity 0.5%Max Total impurity 1.5%Max Isomer *0%Max 4. Water 2.5~3.5% 5. Residue in ignition 0.1%Max 6. Heavy metals *0ppm Max 7. Volatile impurities Ethanol 0.5%Max Ethyl acetate 0.5%Max Petroleum ether 0.1%Max 8. Assay *8.5% min