L-Arginine hydrochloride 98.5-101.0% (by perchloric acid titration), EMPROVE® exp Ph. Eur., BP, JP, USP suitable for use as excipient, SAFC®
Catalog #: CA1.01544.1000
Supplier: EMD MILLIPORE – PCS CA EXCEP
CAS Number: 1119-34-2
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Specifications
- Packaging:Plastic bottle
- Size:1 kg
Specifications
Specification Test Results
- 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
- SAFC®, L-Arginine hydrochloride 98.5-101.0% (by perchloric acid titration), EMPROVE® exp Ph. Eur., BP, JP, USP suitable for use as excipient:
Specification Test Results
About this item
Synonyms: H-L-Arg-OH.HCl,(S)-2-Amino-5-guanidinopentanoic acid hydrochloride,(S)-(+)-Arginine HCl,L-Arginine, hydrochloride,(S)-(+)-Arginine hydrochloride,H-Arg-OH.HCl,L-Arg,L(+)-Arginine monohydrochloride
Melting Pt:>235 °C
:98,5-101,0
:Melting Pt: >235 °C
:Storage Temperature: Ambient
Density:1.42 g/cm³ (20 °C)
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:M.W. 210.66 g/mol
Formula:C₆H₁₅ClN₄O₂
MW:210.66 g/mol
Storage Temperature:Ambient
MDL Number:MFCD00064550
CAS Number:1119-34-2
EINECS:214-275-1
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