L(+)-Histidine monohydrochloride monohydrate 98.5-101.5% (dried basis), Multi-Compendial, Macron Fine Chemicals™

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Avg. Ratings: 0.0 out of 5

Synonyms: H-His-OH.HCl.H2OL-Histidine monohydrochloride monohydrate(S)-(+)-Histidine monohydrochloride monohydrateHis HCl monohydrate(2S)-(+)-Histidine monohydrochloride monohydrateL-Histidine hydrochloride monohydrateL-3-Imidazol-4-ylalanine monohydrochloride monohydrate

Management of Change (MOC) category = R

4942-06EA 429 GBP
MACR4942-05 4942-06 4942-07 4942-09
L(+)-Histidine monohydrochloride monohydrate 98.5-101.5% (dried basis), Multi-Compendial, Macron Fine Chemicals™
L(+)-Histidine monohydrochloride monohydrate
Formula: C₆H₉N₃O₂·HCl·H₂O
MW: 209.63 g/mol
MDL Number: MFCD00151027
CAS Number: 5934-29-2
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Specification Test Results

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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