| Item | FCC12, EP10, USP43 , E955,GB25531andGB4789 | Result | |||
| Appearance | White or almost white 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 Rf value of the major spot in the thin-layer chromatogram of the Sample solution is the same as that of the Standard solution obtained in the test for Related Substances. |
Pass | |||
| Assay | 98.0%–102.0% ,calculated on the anhydrous basis. | 99.69% | |||
| Specific Rotation | +84.0～+87.5° | +85.63° | |||
| Clarity of solution | --- | Clear | |||
| PH ( 10% aqueous solution) | 5.0～7.0 | 5.82 | |||
| Moisture | ≤2.0% | 0.08% | |||
| Methanol | ≤0.1% | Not detected | |||
| Ignited Residue | ≤0.7% | 0.02% | |||
| Arsenic(As) | ≤3ppm | <3ppm | |||
| Heavy metals | ≤10ppm | <10ppm | |||
| Lead | ≤1ppm | Not detected | |||
| Related substances （Other chlorinated disaccharides） |
≤0.5% | <0.5% | |||
| Hydrolysis products （Chlorinated monosaccharides） |
≤0.1% | Complies | |||
| Triphenylphosphine oxide | ≤150ppm | <150ppm | |||
| Total aerobic count | ≤250CFU/g | <20CFU/g | |||
| Yeast & Moulds | ≤50CFU/g | <10CFU/g | |||
| Coliforms | Negative | Nf | |||
| E.coli | Negative | Nf | |||
| S.aureus | Negative | Nf | |||
| Salmonella | Negative | Nf | |||
| Particle size 90% pass through 80 mesh | |||||
| Storage condition:Store in well closed container, dry and cool place | |||||
| Shelf Life: 2 years while stored in original packing under above stated condition. | |||||
| Conclusion: The product complies with FCC12, EP10, USP43, E955,GB25531 andGB4789 standards. | |||||
