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

Supplier: EMD MILLIPORE – PCS CA EXCEP

New Product

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Supplier: EMD MILLIPORE – PCS CA EXCEP

New Product

About this item

CAS Number:74-79-3

Formula:C₆H₁₄N₄O₂

MDL Number:MFCD00002635

:174.2 g/mol

Boiling Pt:368 °C (1013 hPa)

Melting Pt:238 °C

Density:1,3 g/cm³ (20 °C)

Storage Temperature:Ambient

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