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Test Item | Requirement |
Appearance | White crystalline powder or Granular |
Appearance of solution | Conform to EP |
Identification | Meet the requirements |
Assay(105ºC,4h) | 98.0% ~ 102.0% |
Loss on drying | ≤ 4.5% |
Residue on ignition( Sulphate Ash) | ≤ 0.2% |
Conductivity | ≤ 30μs/cm |
PH | 4.5 ~ 6.0 |
Specific rotation | +14.5°~ + 16.5° |
Transmittance | ≥95% |
L-phenylalanine(C) | ≤ 0. 5% |
Diketopiperazine(A) (5-benzyl-3,6-dioxo-2-Poperazineacetic acid) | ≤1.5% |
Other related substances | ≤ 1.5% |
Heavy metals (as Pb) | ≤ 10ppm |
Lead | ≤ 1ppm |
Arseni c | ≤ 3ppm |
Conclusion: Meets the requirements of FCC10, EP9, USP41-NF36 |