Testing Item | Standard | Result |
Appearance | White crystalline granular | White crystalline granular |
Assay | 98.0-102.0 % | 99.20 % |
Specific Rotation [α]D20 | +14.50°~+16.50° | +15.20 ° |
Loss on Drying | ≤ 4.50 % | 2.71 % |
Residue On Ignition(Sulphate Ash) | ≤ 0.20 % | 0.06 % |
pH (0.8% w/v in water) | 4.50 - 6.00 | 5.24 |
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 | 0.992 |
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 | 20-60 Mesh | Conform |