توضیحات

ال آرژنين هيدروكلرايد 5 كيلوگرم كد 101544 كمپاني مرك آلمان

1.01544 SAFC

L-Arginine monohydrochloride

EMPROVE^® EXPERT Ph Eur,BP,JP,USP

Synonym: α-Amino-δ-guanidino valerianic acid hydrochloride, alpha-Amino-delta-guanidino valerianic acid hydrochloride, Arg, (S)–(+)–2-Amino-5-[(aminoiminomethyl)amino]pentanoic acid monohydrochloride, (S)-(+)-Arginine hydrochloride

Analysis Note

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): ≤ 0.20 %
Bacterial endotoxins: ≤ 3.0 I.U./g
Microbiological test (total aerobic microbial count (TAMC)): ≤ 1E+02 CFU/g
Microbiological test (total yeast and mould count (TYMC)): ≤ 1E+01 CFU/g
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., BP, JP, USP.