Complaint
| ITEM | STANDARD | RESULT |
| Identification A(IR) | Infrared spectra of standard and sample should meet each other | Pass |
| Identification B (Retention time of HPLC) | The retention time of the principal peak of the sample solution corresponds to that of the standard solution,as obtained in the Assay. | Pass |
Identification C(By TLC) | The Rf value of the major spot in the thin-layer chromatogram of the Product Preparation is the same as that of the Standard Preparation obtained in the test for Related Substances. | Pass |
| Appearance | White crystalline powder | Pass |
| Assay,% | 98.0~102.0 | 99.94 |
| Specific Rotation,º | +84.0~+87.5 | +86.1 |
| Moisture,% | ≤2.0 | 0.1 |
| PH (10% aqucous solution) | 5.0-7.0 | 5.62 |
| Ignited Residue,% | ≤0.7 | 0.1 |
| Methanol,% | ≤0. 1 | 0.01 |
| Heavy Metals (as lead) ,mg/kg | ≤10 | <10 |
| Arsenic(As),mg/kg | ≤3 | <1 |
| Lead,mg/kg | ≤1 | Not Detected |
| Triphenylphosphine Oxide,mg/kg | ≤150 | <150 |
| Hydrolysis Products,% | ≤0.1 | Pass |
| Related Substances,% | ≤0.5 | Pass |
| Total Aerobic count,cfu/g | ≤250 | 30 |
| Yeasts & moulds,cfu/g | ≤50 | 10 |
| Coliform,MPN/g | <3.0 | <3.0 |
| E.coli | Negative | Negative |
| S.aureus | Negative | Negative |
| Salmonella | Negative | Negative |
| Storage condition | Store in well closed container, in dry and cool place, at a temperature not exceeding 21C. | |
| Conclusion | The quality in conformity with the E-955/USP 36 / FCC 8 | |
