Description
| L-Leucine | CP2020 | EP11 | USP2023 | USP24 | AJI92 |
| Assay | ≥98.5% | 98.5-101.0% | 98.5-101.5% | 98.5-101.5% | 99.0-100.5% |
| PH | 5.5-6.5 | / | 5.5-7.0 | 5.5-7.0 | 5.5-6.5 |
| Lecithin | / | / | / | / | / |
| Binder content | / | / | / | / | / |
| Specific rotation[a]D20 | +14.9°-+16.0° | +14.5°-+16.5° | / | / | +14.9°-+16.0° |
| Specific rotation[a]D25 | / | / | +14.9°-+17.3° | +14.9°-+17.3° | / |
| Transmittance(T430) | ≥98.0% | / | / | / | ≥98.0% |
| Appearance of solution | / | clear & colorless ≤BY6 | / | / | / |
| Bulk Density | / | / | / | / | / |
| Tapped Density | / | / | / | / | / |
| Chloride(Cl) | ≤0.02% | ≤0.02% | ≤0.05% | ≤0.05% | ≤0.02% |
| Ammonium(NH4) | ≤0.02% | ≤0.02% | / | / | ≤0.02% |
| Sulfate(SO4) | ≤0.02% | ≤0.03% | ≤0.03% | ≤0.03% | ≤0.02% |
| Iron(Fe) | ≤10PPM | ≤10PPM | ≤30PPM | ≤30PPM | ≤10PPM |
| Heavy metals(Pb) | ≤10PPM | / | / | ≤15PPM | ≤10PPM |
| Arsenic | ≤1PPM | / | / | ≤1.5PPM | ≤1PPM |
| Lead | / | / | / | / | / |
| Cadmium | / | / | / | / | / |
| Mercury | / | / | / | / | / |
| Other amino acids | ≤0.5% | / | Individual impurities≤0.5% Total impurities≤2.0% |
/ | conforms |
| Ninhydrin-positive substances | / | Impurity A at 570 nm≤0.8% Each impruity ≤0.2% Total ≤1.0% |
/ | / | / |
| Particle Size Range | / | / | / | / | / |
| Loss on drying | ≤0.20% | ≤0.50% | ≤0.2% | ≤0.2% | ≤0.20% |
| Residue on ignition | ≤0.10% | ≤0.10% | ≤0.4% | ≤0.4% | ≤0.10% |
| Organic volatile impurities | / | / | / | conforms | / |
| Endotoxin | <25EU/g | <25EU/g | <25EU/g | / | / |
| Total plate count | ≤ 1000 CFU/g | ≤ 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 | ≤ 100 CFU/g |
| L-Leucine | High Purity | Instant | Granulation |
| Assay | ≥98.5% | ≥95.0% | ≥95% |
| PH | / | / | / |
| Lecithin | / | 0.5～1.0% | / |
| Binder content | / | / | ≤5% |
| Specific rotation[a]D20 | +14.9°-+16.0° | / | / |
| Specific rotation[a]D25 | / | / | / |
| Transmittance(T430) | ≥98.0% | ≥98.0% | / |
| Appearance of solution | / | / | / |
| Bulk Density | / | ≥0.25g/ml | ≥0.50g/ml |
| Tapped Density | / | ≥0.30g/ml | ≥0.55g/ml |
| Chloride(Cl) | ≤0.01% | / | / |
| Ammonium(NH4) | / | / | / |
| Sulfate(SO4) | ≤0.02% | / | / |
| Iron(Fe) | / | / | / |
| Heavy metals(Pb) | / | ≤10ppm | ≤10ppm |
| Arsenic | / | ≤1ppm | ≤1ppm |
| Lead | / | ≤3ppm | ≤3ppm |
| Cadmium | / | ≤1ppm | ≤1ppm |
| Mercury | / | ≤0.3ppm | ≤0.1ppm |
| Other amino acids | Individual impurities≤0.2% Total impurities≤1.0% |
/ | / |
| Ninhydrin-positive substances | / | / | / |
| Particle Size Range | / | ≥95% through 80 mesh | ≥90% through 20 mesh ≤30% through 80 mesh |
| Loss on drying | ≤0.20% | ≤1.0% | ≤2.0% |
| Residue on ignition | / | ≤0.50% | ≤0.4% |
| Organic volatile impurities | / | / | / |
| Endotoxin | / | / | / |
| Total plate count | ≤ 1000 CFU/g | ≤ 1000 CFU/g | ≤ 1000 CFU/g |
| Moulds & Yeasts | ≤ 100 CFU/g | ≤ 100 CFU/g | ≤ 100 CFU/g |
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