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

Supplier: Avantor Performance Materials
Warning


Management of Change (MOC) category = R

4932-06EA 508 EUR
4932-06 4932-09 MACR4932-05 MACR4932-37 4932-07 MACR4932-36
L(+)-Arginine 98.5-101.5% (dried basis) USP, FCC, Multi-Compendial, Macron Fine Chemicals™
L(+)-Arginine

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Specification Test Results

Meets U.S.P Requirements
Meets B.P. Chemical Specifications
Meets E.P. Chemical Specifications
GMP Manufactured Product
Meets J.P. Chemical Specifications
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
USP - Assay (C₆H₁₄N₄O₂) (dried basis) 98.5 - 101.5 %
USP - Identification Passes Test
USP - Specific Rotation [Å]²⁵ ^D (+) 26.3 - 27.7 Degree
USP - Loss on Drying at 105°C ≤ 0.5 %
USP - Chloride (Cl) ≤ 0.05 %
USP - Residue on Ignition ≤ 0.3 %
USP - Sulfate (SO₄) ≤ 0.03 %
USP - Iron (Fe) ≤ 0.003 %
USP - Related Compounds - Individual Impurities ≤ 0.5 %
USP - Related Compounds - Total Impurities ≤ 2.0 %
EP/BP - Assay (C₆H₁₄N₄O₂) (dried basis) 98.5 - 101.0 %
EP/BP - Identification A Passes Test
EP/BP - Identification C Passes Test
EP/BP - Appearance of Solution Passes Test
EP/BP - Specific Rotation [Å]²º^D (+) 25.5 - 28.5 Degree
EP/BP-Ninhydrin-Positive Substances-Each ≤ 0.2 %
EP/BP-Ninhydrin-Positive Substances-Total Impurities ≤ 0.5 %
EP/BP - Chloride (Cl) ≤ 200 ppm
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 - Identification Passes Test
JP - Optical rotation, 20° C (+) 26.9 - 27.9 Degree
JP - pH (1:10) 10.5 - 12.0
JP - Clarity and Color of Solution Passes Test
JP - Chloride (Cl) ≤ 0.021 %
JP - Sulfate (SO₄) ≤ 0.028 %
JP - Ammonium (NH₄) ≤ 0.02 %
JP - Heavy Metals (as Pb) ≤ 10 ppm
JP - Iron (Fe) ≤ 10 ppm
JP - Related Substances Passes Test
JP - Loss on Drying at 105°C ≤ 0.30 %
JP - Residue after Ignition ≤ 0.1 %
JP - Assay (C₆H₁₄N₄O₂)(dried basis) 98.5 - 101.0 %
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.

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