Items

Specification

Results

Appearance

White crystalline powder

Qualified

Identification(IR)

Complied  

Complied  

Specific rotation [a]d20⁰

-30.5° ----  -35.5°

-34.7°

State of solution (transmittance)

  ≥95.0%

98.8%

Chloride(cl)

≤0.04%

 0.030%

Sulfate(so₄)  

 ≤ 0.03%

   0.015%

Iron(fe)

 ≤20ppm

 6ppm

Heavy metals(pb)   

   ≤10ppm

 1ppm

Arsenic (as₂o₃)

 ≤1ppm

    0.1ppm

Other amino acids

Chromatographically  Not detectable   

Qualified

Loss on drying

≤ 0.3%

0.18%

Residue on ignition

≤0.1%

0.040%

Assay   

98.5---101.0%

99.7%

pH 

2.0 ----3.5

2.74

Conclusion: The drug superscript meets standards of AJI92 standard