L-Arginine hydrochloride USP, Multi-Compendial, J.T.Baker®
Supplier: Avantor
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
2067-06
2067-06EA
33018.86
INR
2067-06
2067-07
L-Arginine hydrochloride USP, Multi-Compendial, J.T.Baker®
L-Arginine hydrochloride
Formula:
C₆H₁₅ClN₄O₂ MW: 210,66 g/mol Melting Pt: 218 °C Density: 1,42 g/cm³ (20 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00064550 CAS Number: 1119-34-2 EINECS: 214-275-1 Merck Index: 13,00785 |
Specification Test Results
GMP Manufactured Product | |
Meets B.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
Meets U.S.P Requirements | |
Meets J.P. Chemical Specifications | |
Preserve in well-closed containers. | |
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 % |
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 | ≤ 0.20 % |
No Class 1,2,3 or other solvents are used or produced in the | ≤ 0.10 % |
manufacturing or purification of the product. |
|
No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. | Passes Test |
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. | For Information Only |
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