L(+)-Arginine 98.5-101.0%, EMPROVE® EXPERT Ph. Eur., JP, USP suitable for use as excipient, SAFC®
:74-79-3
:
:C₆H₁₄N₄O₂
:MFCD00002635
:174.2 g/mol
:368 °C (1013 hPa)
:238 °C
:1.3 g/cm³ (20 °C)
:Ambient
:200-811-1
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- 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