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Items Specifications Results
Appearance White crystalline powder White crystalline powder
Identification B) IR
D)"Chlorides" Complies
Solubility Freely soluble in water and in methanol,very slightly soluble in acetone Complies
Appearance of solution Clear and colorless Complies
Acidity According to EP Complies
Heavy metals ≤20ppm ≤20ppm
Water   ≤0.5% 0.23%
Sulphated ash   ≤0.1% 0.04%
Optical rotation -0.10~~+0.10 -0.0
Impurity  E(TLC)   ≤0.2% ≤0.2%
Related
substance(HPLC) Impurity A ≤0.2%
Any other impurity ≤0.1%
Total impurities ≤0.4% 0.04%
0.06%
0.18%
Assay 99.0-101.0% 99.98%
  
  
Conclusion Complies with  EP5.0

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