L(+)-Histidin 98,5-101,5% (Trockenmasse) USP, FCC, Multikompendial, Macron Fine Chemicals™
Lieferant: Avantor Performance Materials
Synonyme:
(S)-(+)-2-Amino-3-(4-imidazoyl)propansäure
, His
, L-3-Imidazol-4-ylalanin
, (2S)-(+)-Histidin
, H
, (S)-(+)-Histidin
, H-His-OH
Veränderungsmanagement-Kategorie= R
MACR4935-06EA
1310.27
EUR
MACR4935-06
MACR4935-07
MACR4935-09
MACR4935-76
L(+)-Histidin 98,5-101,5% (Trockenmasse) USP, FCC, Multikompendial, Macron Fine Chemicals™
L(+)-Histidin
|
Formel:
C₆H₉N₃O₂ Molecular Weight: 155,16 g/mol Dichte: 1,44 g/cm³ |
MDL:
MFCD00064315 CAS-Nummer: 71-00-1 |
Spezifikation Testergebnisse
| Meets B.P. Chemical Specifications | |
| Meets J.P. Chemical Specifications | |
| GMP Manufactured Product | |
| Meets U.S.P Requirements | |
| Meets E.P. Chemical Specifications | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (C₆H₉N₃O₂) (dried basis) | 98.5 - 101.5 % |
| USP - Identification | Passes Test |
| USP - Specific Rotation [Å]²⁵ ^D (+) | 12.6 - 14.0 Degree |
| USP - pH | 7.0 - 8.5 |
| USP - Loss on Drying at 105°C | ≤ 0.2 % |
| USP - Residue on Ignition | ≤ 0.4 % |
| USP - Chloride (Cl) | ≤ 0.05 % |
| 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 (C₆H₉N₃O₂) (dried basis) | 98.5 - 101.0 % |
| EP/BP - Identification A | Passes Test |
| EP/BP - Identification B | Passes Test |
| EP/BP - Appearance of Solution | Passes Test |
| EP/BP - Specific Rotation [Å]²º^D (+) | 11.4 - 12.4 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 % |
| Endotoxin Concentration, IU/mg ,For Information Only | |
| JP - Assay (C6H9N3O2) (dried basis) | 99.0 - 101.0 % |
| JP - Ammonium (NH₄) | ≤ 0.02 % |
| JP - Chloride (Cl) | ≤ 0.021 % |
| JP - Clarity and Color of Solution | Passes Test |
| JP - Heavy Metals (as Pb) | ≤ 10 ppm |
| JP - Iron (Fe) | ≤ 10 ppm |
| JP - Identification | Passes Test |
| JP - Loss on Drying at 105°C | ≤ 0.30 % |
| JP- Optical Rotation [Å]²º^D (+) | 11.8 - 12.8 Degree |
| JP - Related Substances | Passes Test |
| JP - pH | 7.0 - 8.5 |
| JP - Residue on Ignition | ≤ 0.10 % |
| JP - Sulfate (SO₄) | ≤ 0.028 % |
| 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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