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TEST ITEMS | SPECIFICATION | RESULTS | ||
Description | Sterilized and Injectable Grade and White or Practically White Crystalline Powder | |||
Identification | IR Spectrum HPLC | Positive | ||
Solubility | Practically insoluble in water,very Solublein acetonechloride, freely soluble in fatty oils | Positive | ||
Specific Rotation | +82°~+88° | +84.5° | ||
Loss on drying | ≤ 0.50% | ≤ 0.21% | ||
Melting Point | 34~39 ºC | 35~38 ºC | ||
Assay | 97.0% ~ 102.0% | 99.18% | ||
Specific Rotation | +77°~+82° | +78.9° | ||
Free Heptanoch Acid | ≤ 0.6ml | Confirms | ||
Related Substance(TLC)
| Impurities A,B,C,D,E,F,G≤ 0.5% Unspecifities≤ 0.1% Total ≤ 1.0% Disregard limit ≤ 0.05% | Confirms | ||
Confirms | ||||
Conclusion | This batchcomplieswith BP2009 |