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Update to Avantor’s response to the coronavirus (COVID-19) pandemic

L(+)-Arginine 98.5-101.0%, EMPROVE® EXPERT Ph. Eur., JP, USP suitable for use as excipient, SAFC®

Supplier: EMD MILLIPORE - PCS - GPS

1.01587.1000 1.01587.9010
EM1.01587.1000CS 5758.69 USD InStock
EM1.01587.1000 EM1.01587.9010
L(+)-Arginine 98.5-101.0%, EMPROVE® EXPERT Ph. Eur., JP, USP suitable for use as excipient, SAFC®
L(+)-Arginine
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 (*).

Certificaciones: Corresponds to Ph. Eur., JP, USP.


Formula: C₆H₁₄N₄O₂
Boiling Pt: 368 °C (1013 hPa)
Melting Pt: 238 °C (dec.)
Density: 1.3 g/cm³ (20 °C)
Storage Temperature: Ambient
 MDL Number: MFCD00002635
CAS Number: 74-79-3
EINECS: 200-811-1
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Specification Test Results
Assay (perchloric acid titration, calculated on dried substance) 98.5 - 101.0 %
Identity (IR-spectrum) passes test
Appearance white to almost white, crystalline powder or colorless 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, CO₂-free water) clear and colorless
Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 250 g/l, calc. on dried substance) +25.5 to +28.5
Spec. rotation (α 25/D, 80 g/l, hydrochloric acid 6 mol/l, calc. on dried substance) +26.3 to +27.7
Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 6 mol/l,previously dried substance) +26.9 to +27.9
pH (100 g/l, CO₂-free water) 10.5 - 12.0
Chloride (Cl) ≤ 200 ppm
Sulfate (SO₄) ≤ 200 ppm
Heavy metals (as Pb) ≤ 10 ppm
Cu (Copper)* ≤ 25 ppm
Fe (Iron) ≤ 10 ppm
Fe (Iron) (ICP) ≤ 10 ppm
Mn (Manganese) ≤ 25 ppm
Mo (Molybdenum)* ≤ 2.5 ppm
Ni (Nickel)* ≤ 2 ppm
Zn (Zinc) ≤ 130 ppm
Related Compounds, total (TLC) ≤ 0.5 %
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; 3 h) ≤ 0.30 %
Bacterial endotoxins ≤ 2.0 I.U./g

 

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