L-Arginina cloridrato 98.5-101.0% (by perchloric acid titration), EMPROVE® EXPERT Ph. Eur., BP, JP, USP adatto a essere utilizzato come eccipiente, SAFC®
Fornitore: MERCK PRODUCTION CHEMICALS
Synonyms:
(S)-(+)-Arginina cloridrato, L(+)-Arginina cloridrato
1.01544.1000
1.01544.5000
1.01544.9010
1.01544.1000EA
706
EUR
1.01544.1000
1.01544.5000
1.01544.9010
L-Arginina cloridrato 98.5-101.0% (by perchloric acid titration), EMPROVE® EXPERT Ph. Eur., BP, JP, USP adatto a essere utilizzato come eccipiente, SAFC®
L-Arginina cloridrato
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
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Formula:
C₆H₁₅ClN₄O₂ Peso molecolare: 210,66 g/mol Punto di fusione: 218 °C Densità: 1,42 g/cm³ (20 °C) Temperatura di stoccaggio: Ambiente |
MDL Number:
MFCD00064550 CAS Number: 1119-34-2 EINECS: 214-275-1 Merck Index: 13,00785 |
Risultati del test di specificazione
| Assay (perchloric acid titration, calculated on dried substance) | 98.5 - 101.0 % |
| Identity (IR-spectrum) | passes test |
| Identity (Chloride) | passes test |
| Appearance | white to almost white or colorless, irregular crystals |
| Appearance of solution (50 g/l; water) | clear and not more intense in color than reference solution BY₆ |
| Appearance of solution (100 g/l, water) | clear and colorless |
| pH (100 g/l, CO₂-free water) | 4.7 - 6.2 |
| Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 250 g/l, calc. on dried substance) | +21.0 to +23.5 |
| Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 6 mol/l, calc. on dried substance) | +21.4 to +23.6 |
| Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 6 mol/l,previously dried substance) | +21,5 to +23,5 |
| Chloride (Cl) (argentometric) | 16.5 - 17.1 % |
| Sulfate (SO₄) | ≤ 200 ppm |
| Heavy metals (as Pb) | ≤ 10 ppm |
| As (Arsenic) | ≤ 2 ppm |
| Fe (Iron) | ≤ 10 ppm |
| NH₄ (Ammonium) | ≤ 200 ppm |
| Related Compounds, total (TLC) | ≤ 0.5 % |
| Related substances (TLC) | passes test |
| Ninhydrin-positive substances (LC) (any ninhydrin-positive impurity) | ≤ 0.2 % |
| Ninhydrin-positive substances (LC) (ammonium (570 nm)) | ≤ 0.02 % |
| Ninhydrin-positive substances (LC) (total impurities) | ≤ 0.5 % |
| Residual solvents (ICH Q3C) | excluded by manufacturing process |
| Sulfated ash (600 °C) | ≤ 0.1 % |
| Loss on drying (105 °C, 2 h) | ≤ 0.2 % |
| Bacterial endotoxins | ≤ 3.0 I.U./g |
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