L-Arginine hydrochloride 98.5-101.5% (dried basis) USP, FCC, Multi-Compendial, Macron Fine Chemicals™

Supplier: Avantor Performance Materials

Synonyms: H-L-Arg-OH.HCl, (S)-2-Amino-5-guanidinopentanoic acid hydrochloride, (S)-(+)-Arginine HCl, H-Arg-OH·HCl, L-Arginine, hydrochloride, (S)-(+)-Arginine hydrochloride, H-Arg-OH.HCl, L-Arg, L(+)-Arginine monohydrochloride, L(+)-Arginine hydrochloride

Management of Change (MOC) category = R

MACR4930-06EA 257 SGD
MACR4930-06 MACR4930-09 MACR4930-07 MACR4930-05
L-Arginine hydrochloride 98.5-101.5% (dried basis) USP, FCC, Multi-Compendial, Macron Fine Chemicals™
L-Arginine hydrochloride
Formula: C₆H₁₅ClN₄O₂
MW: 210,66 g/mol
MDL Number: MFCD00064550
CAS Number: 1119-34-2

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Specification Test Results

GMP Manufactured Product
Meets B.P. Chemical Specifications
Meets E.P. Chemical Specifications
Meets J.P. Chemical Specifications
Meets U.S.P Requirements
Store in well-closed,light-resistant containers
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
USP - Assay (C₆H₁₄N₄O₂·HCl) (dried basis) 98.5 - 101.5 %
USP - Identification Passes Test
USP - Specific Rotation [Å]²º^D (+) 21.4 - 23.6 Degree
USP - Loss on Drying at 105°C ≤ 0.2 %
USP - Residue on Ignition ≤ 0.1 %
USP - Sulfate (SO₄) ≤ 0.03 %
USP - Related Compounds - Individual Impurities ≤ 0.5 %
USP - Related Compounds - Total Impurities ≤ 2.0 %
USP - Chloride (Cl) 16.5 - 17.1 %
FCC - Assay (C₆H₁₄N₄O₂·HCl) (dried basis) 98.5 - 101.5 %
FCC - Identification Passes Test
FCC - Loss on Drying ≤ 0.3 %
FCC - Residue after Ignition ≤ 0.10 %
FCC - Specific Rotation [Å]²º^D (+) 21.3 - 23.5 Degree
FCC - Lead (Pb) ≤ 5 mg/kg
EP/BP - Assay (C₆H₁₄N₄O₂·HCl) (dried basis) 98.5 - 101.0 %
EP/BP - Identification A Passes Test
EP/BP - Identification B Passes Test
EP/BP - Identification E Passes Test
EP/BP - Appearance of Solution Passes Test
EP/BP - Specific Rotation [Å]²º^D (+) 21.0 - 23.5 Degree
EP/BP-Ninhydrin-Positive Substances-Each ≤ 0.2 %
EP/BP-Ninhydrin-Positive Substances-Total Impurities ≤ 0.5 %
EP/BP - Sulfate (SO₄) ≤ 300 ppm
EP/BP - Ammonium (NH₄) ≤ 0.02 %
EP/BP - Iron (Fe) ≤ 10 ppm
EP/BP - Loss on Drying ≤ 0.5 %
EP/BP - Ash (sulfated) ≤ 0.1 %
JP - Assay (C₆H₁₄N₄O₂·HCl) (dried basis) 98.5 - 101.0 %
JP - Identification Passes Test
JP - Optical Rotation (+) 21.5 - 23.5 Degree
JP - pH (1 in 10) 4.7 - 6.2
JP - Clarity and Color of Solution Passes Test
JP - Sulfate (SO₄) ≤ 0.028 %
JP - Ammonium (NH₄) ≤ 0.02 %
JP - Heavy Metals (as Pb) ≤ 20 ppm
JP - Arsenic (As) ≤ 2 ppm
JP - Related Substances Passes Test
JP - Loss on Drying at 105°C ≤ 0.20 %
JP - Residue after Ignition ≤ 0.10 %
Endotoxin Concentration, IU/mg, For Information Only ≤ 20 ppm
No Class 1,2,3 or other solvents are used or produced in the ≤ 2 ppm
manufacturing or purification of the product. Passes Test
Elemental Impurities (USP (232), EP 5.20) - Information on elemental ≤ 0.10 %
impurities for this product is available on the associated Product
Regulatory Data Sheet and elemental impurity profile report.

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