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

New Product

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

: EMD MILLIPORE – PCS CA EXCEP

New Product

:1119-34-2

:C₆H₁₅ClN₄O₂

:MFCD00064550

:210.66 g/mol

:13,00785

:>235 °C

:1.42 g/cm³ (20 °C)

:Ambient

:214-275-1

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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