Product Specifications:

Appearance:- White or almost white crystalline powder

Appearance of solution:-

·        1M hydrochloric acid:- NMT2%

·        2M ammonia:- NMT2%

Specific optical rotation:- +280°~+305°

pH:-3.5~5.5

Water:-  12.0~15.0%

Related Substances:-

  Impurity D:-NMT1.0%

  Impurity F:-NMT1.0%

  Impurity F:-NMT1.0%

  Impurity I:-NMT1.0%

  Impurity M:-NMT1.0%

  Any individual unspecified:-

·        Impurity:- NMT2.0%

·        Total impurities:- NMT2.0%

Sulphated ash:- NMT0.5%

Dimethylanillne:- NMT20ppm

Residual solvents:-

·        Dichloromethane:-  NMT600ppm

·        Triethylamine:-  NMT320ppm

·        Acetone:-  NMT3000ppm

Assay(Calculated as anhydrous substance):- 96.0-102.0%

Identification:- HPLC IR