L(+)-Asparagina monoidrato 99.0-101.0% (dry basis), EMPROVE® EXPERT Ph. Eur. adatto a essere utilizzato come eccipiente, SAFC®
Fornitore: MERCK PRODUCTION CHEMICALS
Synonyms:
(S)-(+)-Asparagina monoidrato
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 (*).
Corresponds to Ph. Eur.
Formula:
C₄H₈N₂O₃·1H₂O Peso molecolare: 150,13 g/mol Punto di fusione: 215…217 °C Densità: 1,567 g/cm³ (20 °C) Temperatura di stoccaggio: Ambiente |
MDL Number:
MFCD00151038 CAS Number: 5794-13-8 EINECS: 200-735-9 Merck Index: 14,00837 |
Risultati del test di specificazione
Assay (perchloric acid titration, calculated on dried substance) | 99.0 - 101.0 % |
Identity (IR-spectrum) | passes test |
Appearance | white to almost white crystalline powder or colorless crystals |
Appearance of solution (20 g/l, CO₂-free water) | clear and colorless |
Spec. rotation (α 20/D, 100 g/l, hydrochloric acid 3 mol/l, calc. on dried substance) | +33.7 to +36.0 |
pH (20 g/l, CO₂-free water) | 4.0 - 6.0 |
Chloride (Cl) | ≤ 200 ppm |
Sulphate (SO₄) | ≤ 200 ppm |
Fe (Iron) | ≤ 10 ppm |
NH₄ (Ammonium) | ≤ 0.1 % |
Aspartic acid | ≤ 0.5 % |
Ninhydrin - positive substances (TLC) (Glutamic acid) | ≤ 0.5 % |
Ninhydrin - positive substances (TLC) (any other impurity) | ≤ 0.5 % |
Ethanol (HS-GC) | ≤ 5000 ppm |
Other residual solvents (ICH Q3C) | excluded by manufacturing process |
Sulfated ash (600 °C) | ≤ 0.1 % |
Loss on drying (130 °C, 3 h) | 10.5 - 12.5 % |
Bacterial endotoxins | ≤ 3.0 I.U./g |
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