L(+)-Histidin Hydrochlorid Monohydrat 98,5-101,5% (Trockenmasse), Multikompendial, Macron Fine Chemicals™
Lieferant: Avantor Performance Materials
Synonyms:
H-His-OH.HCl.H2O
, His HCl Monohydrat
, (S)-(+)-Histidin Hydrochlorid Monohydrat
, L-3-Imidazol-4-ylalanin Hydrochlorid Monohydrat
, (S)-(+)-2-Amino-3-(4-imidazoyl)propansäure Hydrochlorid Monohydrat
, (2S)-(+)-Histidin Hydrochlorid Monohydrat
Veränderungsmanagement-Kategorie= R
MACR4942-05EA
0
CHF
MACR4942-76
MACR4942-05
4942-06
4942-07
4942-09
L(+)-Histidin Hydrochlorid Monohydrat 98,5-101,5% (Trockenmasse), Multikompendial, Macron Fine Chemicals™
L(+)-Histidin Hydrochlorid Monohydrat
|
Formel:
C₆H₉N₃O₂·HCl·H₂O MW: 209,63 g/mol |
MDL Number:
MFCD00151027 CAS-Nummer: 5934-29-2 |
|
Spezifikation Testergebnisse
| Meets B.P. Chemical Specifications | |
| Meets E.P. Chemical Specifications | |
| Meets J.P. Chemical Specifications | |
| GMP Manufactured Product | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| EP/BP - Assay (C₆H₉N₃O₂·HCl) (dried basis) | 98.5 - 101.0 % |
| EP/BP - Identification A | Passes Test |
| EP/BP - Identification B | Passes Test |
| EP/BP - Identification C | Passes Test |
| EP/BP - Identification F | Passes Test |
| EP/BP - Appearance of Solution | Passes Test |
| EP/BP - pH | 3.0 - 5.0 |
| EP/BP - Specific Rotation [Å]²º^D (+) | 9.2 - 10.6 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 at 150°C | 7.0 - 10.0 % |
| EP/BP - Ash (sulfated) | ≤ 0.1 % |
| JP - Identification | Passes Test |
| JP - Optical Rotation (+) | 9.2 - 10.6 |
| JP - pH | 3.5 - 4.5 |
| JP - Clarity and Color of Solution | Passes Test |
| 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 - Water | 7.2 - 10.0 % |
| JP - Residue on Ignition | ≤ 0.10 % |
| JP - Assay (anhydrous basis) | 99.0 - 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. | |
| Metallic Residues: No metal catalysts or metal reagents, as defined by | |
| EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of | |
| this material. |
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