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

Supplier: AVANTOR PERFORMANCE MATERIAL LLC

Supplier: AVANTOR PERFORMANCE MATERIAL LLC

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

Formula:C₆H₁₅ClN₄O₂

MW:210.66 g/mol

Density:1.42 g/cm³

MDL Number:MFCD00064550

CAS Number:1119-34-2

:Length:

:Width:

:Height:

:Ø

:Thickness:

:98,5-101,5

:Management of Change (MOC) category = R

:Boiling Pt:

:Melting Pt:

:Melting Pt: 218 °C

:Flash Pt:

:M.W. 210.66 g/mol

:218

:M.O.C. Category R

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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:
No Class 1,2,3 or other solvents are used or produced in the:
manufacturing or purification of the product.:
Elemental Impurities (USP (232), EP 5.20) - Information on elemental:
impurities for this product is available on the associated Product:
Regulatory Data Sheet and elemental impurity profile report.:
Macron Fine Chemicals™, L-Arginine hydrochloride 98.5-101.5% (dried basis) USP, FCC, Multi-Compendial: