L(+)-Arginine hydrochloride 98.5-101.0% (by perchloric acid titration), EMPROVE® exp Ph. Eur., BP, JP, USP suitable for use as excipient

Supplier: MilliporeSigma

Synonyms: (S)-(+)-Arginine hydrochlorideL-Arginine , hydrochlorideL-(+)-Arginine MonohydrochlorideL-Arginine monohydrochlorideH-L-Arg-OH.HClH-Arg-OH.HCl

1.01544.1000 1.01544.5000 1.01544.9010 1.01544.1000 1.01544.9010
EM1.01544.1000EA 619.75 USD
EM1.01544.1000 EM1.01544.5000 CA1.01544.9010 CA1.01544.1000 EM1.01544.9010
L(+)-Arginine hydrochloride 98.5-101.0% (by perchloric acid titration), EMPROVE® exp Ph. Eur., BP, JP, USP suitable for use as excipient
L(+)-Arginine hydrochloride

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 (*).

Formula: C₆H₁₅ClN₄O₂
MW: 210.66 g/mol
Melting Pt: >235 °C
Density: 1.42 g/cm³ (20 °C)
Storage Temperature: Ambient
MDL Number: MFCD00064550
CAS Number: 1119-34-2
EINECS: 214-275-1

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Specification Test Results

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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