Imprimer

L-Arginine chlorhydrate 98.5-101.0% (par titration à l'acide perchlorique), EMPROVE® EXPERT JP, USP, BP, Ph. Eur., très pur pouvant être utilisé comme excipient, SAFC®

Marques : MERCK PRODUCTION CHEMICALS
Ratings: Ecrire un avis

Total Evaluation: 0
Moyenne des Notes : 0.0 sur 5

Synonyme(s): (S)-(+)-Arginine chlorhydrate, L(+)-Arginine chlorhydrate

1.01544.1000 1.01544.5000 1.01544.9010
1.01544.1000EA 1030 EUR
1.01544.1000 1.01544.5000 1.01544.9010
L-Arginine chlorhydrate 98.5-101.0% (par titration à l'acide perchlorique), EMPROVE® EXPERT JP, USP, BP, Ph. Eur., très pur pouvant être utilisé comme excipient, SAFC®
L-Arginine chlorhydrate

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 (*).

Formule: C₆H₁₅ClN₄O₂
Poids moléculaire: 210.66 g/mol
Point de fusion: 218
Densité: 1.42 g/cm³ (20 °C)
Température de stockage: Température ambiante
Numéro MDL: MFCD00064550
Numéro CAS: 1119-34-2
EINECS: 214-275-1
Indice Merck: 13,00785

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Résultats des tests de spécification

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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