精氨酸（JXFL100024国）L-Arginine 101587

规格
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
Sulphate (SO₄)	≤ 200 ppm
Heavy metals (as Pb)	≤ 10 ppm
Fe (Iron)	≤ 10 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
Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present.
Corresponds to Ph. Eur., JP, USP.

货号：101587

品名：L-Arginine suitable for use as excipient EMPROVE® Essential Ph Eur,USP

中文名：精氨酸（JXFL1300024国）

内毒素：≤2.0 I.U./g