Item | Standard | Result |
Characteristics | A white or yellowish white powder .Odorless or almost.bygroscopic | Conforms |
Identification | A:B:C The positive reaction. | Conforms |
Solubility | Very soluble in water, insoluble in acetone , chloroform, ether. | Conforms |
Specific optical rotation | +53.5°~ +59.0° | +58.0° |
Acidity of alkalinity | 5.0~7.5 | 6.7 |
Impurity A | 2%max | Conforms |
Impurity C | 3% ~15% | Conforms |
Any other impurity | not more than the area of the principal peak | Conforms |
in the chromatogram obtained with RS(B)5% |
Total other impurity | not more than 3times the area of the principal peak | Conforms |
in the chromatogram obtained with RS(B)15% |
Disregard limit | ae of the principal peak in the chromatogram | Conforms |
obtained with RS(C)1% |
Loss on drying (pct) | max8.0 | 5.0% |
Sulphate | 27.0-31.0% | 28.4%max |
Sulphated ash | 1% max | 0.2% |
Microcount limit test | NMT 500 col/g | 10 col/g |
Microcount-yeast and molds | NMT 10 col/g | Conforms |
Microcount-Escherichia coli | Absent | Conforms |
Microcount-Staphy lococcus aureus | Absent | Conforms |
Microcount-Pseudo monas | Absent | |
Assay | ≥680I.U./mg (DRY) | 687I.U./mg DRY 653I.U./mg MOIST |