Complaint
| Test Item | Specification | Result/ Remarks |
| Appearance | White crystalline powder | White crystalline powder |
| Assay | 98.0-102.0 % | 99.30 % |
| Specific Rotation [α]D20 | +14.50°~+16.50° | +15.30 ° |
| Loss on Drying | ≤ 4.50 % | 3.33 % |
| Residue On Ignition(Sulphate Ash) | ≤ 0.20 % | 0.06 % |
| pH (0.8% w/v in water) | 4.50 - 6.00 | 5.26 |
| Diketopiperazine (DKP) 5-benzyl-3.6-dioxo-2-Piperazineacetic acid | ≤ 1.5 % | < 1.5 % |
| Other Related impurities Chromatographic purity | ≤ 2.0 % | < 2.0 % |
| Transmittance | ≥ 0.95 | 0.993 |
| Heavy Metals (as Pb) | ≤ 10 mg/kg | < 10 mg/kg |
| Arsenic (as As) | ≤ 3 mg/kg | < 3 mg/kg |
| Lead | ≤ 1 mg/kg | < 1 mg/kg |
| Residual Solvents | Meet the requirements | Conform |
| Particle Size | 100 Mesh | Conform |
| Packaging | 25kg net weight cardboard drums with 2 inner bags. | |
| Storage | Store under a cool, dry ambient environment. Avoid high heat. | |
| Conclusion | Meet the requirements set forth by the current FCC&USP. | |
