Molecular Formula: C3H7NO2
Molecular Weight: 89.09
CAS No: 56-41-7
L-Alanine | CP2020 | EP11 | EP8 | USP2023 |
Assay | ≥98.5% | 98.5~101.0 % | 98.5~101.0 % | 98.5-101.5% |
PH | 5.5-7.0 | / | / | 5.5-7.0 |
Specific rotation[a]D20 | +14.0°-+15.0° | +13.5°-+15.5° | +13.5°-+15.5° | +13.7°-+15.1° |
Specific rotation[a]D25 | / | / | / | / |
Transmittance(T430) | ≥98.0% | / | / | / |
Appearance of solution | / | clear & colorless ≤BY6 | / | / |
Chloride(Cl) | ≤0.02% | ≤0.02% | ≤0.02% | ≤0.05% |
Ammonium(NH4) | ≤0.02% | ≤0.02% | ≤0.02% | / |
Sulfate(SO4) | ≤0.02% | ≤0.03% | ≤0.03% | ≤0.03% |
Iron(Fe) | ≤10PPM | ≤10PPM | ≤10PPM | ≤30PPM |
Heavy metals(Pb) | ≤10PPM | / | ≤10PPM | / |
Arsenic | ≤1PPM | / | / | / |
Other amino acids | ≤0.5% | / | / | Maleic acid ≤ 0.05% Malic acid ≤ 0.05% Fumaric acid ≤ 0.05% Any unspecified impurity ≤ 0.05% Total impurities≤ 0.20% |
Ninhydrin-positive substances | / | Each impurity≤ 0.1 % Total impurities≤ 0.5 % | / | / |
Loss on drying | ≤0.20% | ≤0.50% | ≤0.50% | ≤0.20% |
Residue on ignition | ≤0.10% | ≤0.10% | ≤0.10% | ≤0.15% |
Endotoxin | < 20 EU/g | < 20 EU/g | / | < 20 EU/g |
Total plate count | ≤ 1000 CFU/g | ≤ 1000 CFU/g | ≤ 1000 CFU/g | ≤ 1000 CFU/g |
Moulds & Yeasts | ≤ 100 CFU/g | ≤ 100 CFU/g | ≤ 100 CFU/g | ≤ 100 CFU/g |
L-Alanine | USP32 | AJI92 |
Assay | 98.5-101.5% | 99.0-101.0% |
PH | 5.5-7.0 | 5.7-6.7 |
Specific rotation[a]D20 | +13.7°-+15.1° | +14.3°-+15.2° |
Specific rotation[a]D25 | / | / |
Transmittance(T430) | / | ≥98.0% |
Appearance of solution | / | / |
Chloride(Cl) | ≤0.05% | ≤0.02% |
Ammonium(NH4) | / | ≤0.02% |
Sulfate(SO4) | ≤0.03% | ≤0.02% |
Iron(Fe) | ≤30PPM | ≤10PPM |
Heavy metals(Pb) | ≤15PPM | ≤10PPM |
Arsenic | / | ≤1PPM |
Other amino acids | Individual impurities≤0.5% Total impurities≤2.0% | conform |
Ninhydrin-positive substances | / | / |
Loss on drying | ≤0.20% | ≤0.20% |
Residue on ignition | ≤0.15% | ≤0.10% |
Endotoxin | / | / |
Total plate count | ≤ 1000 CFU/g | ≤ 1000 CFU/g |
Moulds & Yeasts | ≤ 100 CFU/g | ≤ 100 CFU/g |