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
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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