L-Arginin Hydrochlorid 98,5-101,5% (Trockenmasse) USP, FCC, Multikompendial, Macron Fine Chemicals™
Lieferant: Avantor Performance Materials
Synonyme:
L(+)-Arginin Hydrochlorid
, (S)-(+)-Arginin Hydrochlorid
, L(+)-α-Amino-δ-guanidinovaleriansäure Hydrochlorid
, H-L-Arg-OH.HCl
, (S)-(+)-α-Amino-δ-guanidinovaleriansäure Hydrochlorid
, H-Arg-OH.HCl
Veränderungsmanagement-Kategorie= R
4930-09EA
12416.48
EUR
4930-09
MACR4930-37
MACR4930-05
4930-06
MACR4930-36
4930-07
L-Arginin Hydrochlorid 98,5-101,5% (Trockenmasse) USP, FCC, Multikompendial, Macron Fine Chemicals™
L-Arginin Hydrochlorid
Formel:
C₆H₁₅ClN₄O₂ Molecular Weight: 210,66 g/mol |
MDL:
MFCD00064550 CAS-Nummer: 1119-34-2 |
Spezifikation Testergebnisse
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. |
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