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

Supplier: Avantor Performance Materials
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Avg. Ratings: 0.0 out of 5

Synonyms: L-3-Imidazol-4-ylalanine(S)-(+)-Histidine(S)-2-Amino-3-(4-imidazolyl)propionic acidNSC 137773L-HistidineH-His-OH

Management of Change (MOC) category = R

MACR4935-06EA 1210 GBP
MACR4935-06 MACR4935-07 MACR4935-09 MACR4935-76
L(+)-Histidine 98.5-101.5% (dried basis) USP, FCC, Multi-Compendial, Macron Fine Chemicals™
L(+)-Histidine
Formula: C₆H₉N₃O₂
MW: 155.16 g/mol
Density: 1.44 g/cm³
MDL Number: MFCD00064315
CAS Number: 71-00-1

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Specification Test Results

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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