L(+)-Histidine monohydrochloride monohydrate, Multi-Compendial, J.T.Baker®
Supplier: Avantor
Synonyms:
L-Histidine monohydrochloride monohydrate, (2S)-(+)-Histidine monohydrochloride monohydrate, L-Histidine hydrochloride monohydrate, (S)-(+)-Histidine monohydrochloride monohydrate, His HCl monohydrate, H-His-OH.HCl.H2O, H-His-OH·HCl·H₂O, L-3-Imidazol-4-ylalanine monohydrochloride monohydrate, L-Histidine hydrochloride hydrate
2081-06
2081-06EA
37423.32
INR
2081-06
2081-07
L(+)-Histidine monohydrochloride monohydrate, Multi-Compendial, J.T.Baker®
L(+)-Histidine monohydrochloride monohydrate
Formula:
C₆H₉N₃O₂·HCl·H₂O MW: 209,63 g/mol Melting Pt: 259 °C Density: 1,485 g/cm³ (20 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00151027 CAS Number: 5934-29-2 EINECS: 211-438-9 Merck Index: 13,04741 |
Specification Test Results
Meets B.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
GMP Manufactured Product | |
Meets J.P. Chemical Specifications | |
Store in airtight container. | |
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. | |
No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. | ≤ 10 ppm |
Elemental Impurities (USP 232, EP 5.20) - Information on elemental | ≤ 10 ppm |
impurities for this product is available on the associated Product | Passes Test |
Regulatory Data Sheet and elemental impurity profile report. | 7.2 - 10.0 % |
Elemental Impurities (USP |
|
elemental impurities for this product is available on the associated | |
Product Regulatory Data Sheet and elemental impurity profile report. |
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