L-Arginin Hydrochlorid 98,5-101,5% (Trockenmasse) USP, FCC, Multikompendial, Macron Fine Chemicals™
Lieferant: Avantor Performance Materials
Management of Change (MOC) category = R
4930-06EA
459
CHF
4930-06
4930-09
4930-07
MACR4930-05
L-Arginin Hydrochlorid 98,5-101,5% (Trockenmasse) USP, FCC, Multikompendial, Macron Fine Chemicals™
L-Arginine hydrochloride
|
Formel:
C₆H₁₅ClN₄O₂ |
MDL Number:
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 | ≤ 20 ppm |
| No Class 1,2,3 or other solvents are used or produced in the | ≤ 2 ppm |
| manufacturing or purification of the product. | Passes Test |
| Elemental Impurities (USP (232), EP 5.20) - Information on elemental | ≤ 0.10 % |
| impurities for this product is available on the associated Product | — |
| Regulatory Data Sheet and elemental impurity profile report. |
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