L(+)-Arginine 98.5-101.5% (dried basis) USP, FCC, Multi-Compendial, Macron Fine Chemicals™
Supplier: AVANTOR PERFORMANCE MATERIAL LLC
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Warning
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Synonyms:
L-Arginine
, H-L-Arg-OH
, Arginine
, (S)-(+)-Arginine
, H-Arg-OH
, (S)-2-Amino-5-guanidinopentanoic acid
Management of Change (MOC) category = R
MACR4932-09
MACR4932-07
MACR4932-06
MACR4932-06
MACR4932-07
MACR4932-05
MACR4932-09
MACR4932-05
MK4932-06EA
896.12
USD
CAMK493207
MK4932-06
CAMK4932-09
MK4932-05
MK493207
CAMK4932-05
MK4932-09
CAMK4932-06
L(+)-Arginine 98.5-101.5% (dried basis) USP, FCC, Multi-Compendial, Macron Fine Chemicals™
L(+)-Arginine
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Formula:
C₆H₁₄N₄O₂ MW: 174.2 g/mol |
MDL Number:
MFCD00002635 CAS Number: 74-79-3 |
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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