L(+)-Histidine monohydrochloride monohydrate 98.5-101.0%, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur., Macron Fine Chemicals™

Supplier: Avantor Performance Materials

MACR4938-06EA 239 SGD
MACR4938-06 MACR4938-07 MACR4938-09
L(+)-Histidine monohydrochloride monohydrate 98.5-101.0%, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur., Macron Fine Chemicals™
L(+)-Histidine monohydrochloride monohydrate
Formula: C₆H₉N₃O₂·HCl·H₂O
Melting Pt: 259 °C
Density: 1,485 g/cm³ (20 °C)
Storage Temperature: Ambient
MDL Number: MFCD00151027
CAS Number: 5934-29-2

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Specification Test Results

GMP Manufactured Product
Meets B.P. Chemical Specifications
Meets ChP Chemical Specifications
Meets J.P. Chemical Specifications
Meets U.S.P Requirements
Meets E.P. Chemical Specifications
Preserve in Tight Containers
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
EP/BP - Assay (C6H9N302 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 (.A]2°AO (+) 9.2 - 10.6°
EP/BP-Ninhydrin-Positive Substances-Each ≤0.2%
EP/BP-Ninhydrin-Positive Substances-Total Impurities ≤0.5%
EP/BP - Sulfate (S04) ≤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 - 0ptical Rotation (+) 9.2 - 10.6
JP - pH 3.5 - 4.5
JP - Clarity and Color of Solution Passes Test
JP - Sulfate (S04) ≤0.028%
JP - Ammonium (NH4) ≤0.02%
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%
ChP - Specific Rotation @ 20 °C 8.5 - 10.5°
ChP - Identification 1 (TLC) Passes Test
ChP - Identification 2 (IR) Passes Test
ChP - Acidity or alkalinity (pH) 3.5 - 4.5
ChP - Transmittance of solution ≥ 98.0%
ChP - Chloride Content 16.7 - 17.1%
ChP - Sulfates ≤0.02%
ChP - Ammonium ≤0.02%
ChP - 0ther amino acids (TLC)(<=0.2%, one spot only) Passes Test
ChP - Loss on drying @ 105 °C ≤0.2%
ChP - Residue on ignition ≤0.1%
ChP - Heavy metals ≤0.001%
ChP - Arsenic ≤0.0001%
ChP - Bacterial endotoxin, EU/g ≤6.0
ChP - Assay, dried basis 99.0 - 101.0%
ChP - Iron ≤0.001%

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