Item | FCCVIII, 37-NF32 and E955 | Result |
Appearance | White or almost white crystalline powder | Complies |
Ident IR | The IR absorption spectrum conform the reference spectrum | Pass |
Ident HPLC | The retention time of the principal peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation | Pass |
Ident TLC | The retention time of the principal peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation | Pass |
Assay | 98.0~102.0% | 99.5% |
Specific Rotation | +84.0~+87.5° | +84.0~+87.5° |
Clarity of solution | --- | Clear |
PH (10% aqueous solution) | 5.0~7.0 | 6.1 |
Moisture | ≤2.0% | 0.12% |
Methanol | ≤0.1% | <0.1% |
Ignited Residue | ≤0.7% | 0.10% |
Arsenic(As) | ≤3mg/kg | <3mg/kg |
Heavy metals | ≤10mg/kg | <10mgkg |
Lead | ≤1mg/kg | <1mg/kg |
Related substances | ≤0.5% | <0.5% |
Hydrolysis products | ≤0.1% | Complies |
Total aerobic count | ≤250cfu/g | Conform |
Yeast & Moulds | ≤50cfu/g | Conform |
Mercury(Hg) | <0.1mg/kg | <0.1mg/kg |
Cadminum(Cd) | <0.1mg/kg | <0.1mg/kg |
Coliforms | Negative | Nf |
E.coli | Negative | Nf |
S.aureus | Negative | Nf |
Salmonella | Negative | Nf |
Particle size | 95% pass through 80 mesh |