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L(+)-Histidine 98.5-101.5% (dried basis) USP, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur., Macron Fine Chemicals™

Supplier: MACRON AVANTOR BRAND

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Management of Change (MOC) category = R

MACR4928-06EA 0 INR InStock
MACR4928-06 MACR4928-07
L(+)-Histidine 98.5-101.5% (dried basis) USP, Multi-Compendial, meets analytical specification of ChP, BP, JP, Ph. Eur., Macron Fine Chemicals™
L(+)-Histidine


Formula: C₆H₉N₃O₂
MW: 155.16 g/mol
Melting Pt: 287 °C
Density: 1,44 g/cm³ (20 °C)
Storage Temperature: Ambient
 MDL Number: MFCD00064315
CAS Number: 71-00-1
Merck Index: 13,04741
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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
USP - Assay (C H N 0 ) (dried basis) 98.5 - 101.5%
USP - Identification Passes Test
USP - Specific Rotation [A)25 AO (+) 12.6 - 1.4.0°
USP - pH 7.0 - 8.5
USP - Loss on Orying at 105 °C ≤0.2%
USP - Residue on Ignition ≤0..4%
USP - Chloride (Cl) ≤0.05%
USP - Sulfate (S04) ≤0.03%
USP - Iron (Fe) ≤0.003%
USP - Related Compounds - Individual Impurities ≤0.5%
USP - Related Compounds - Total Impurities ≤2.0%
EP/BP - Assay (C H N 0 ) (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 [A)2°AO (+) 11..4 - 12..4°
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 (S04) ≤300 ppm
EP/BP - Ammonium (NH4) ≤0.02%
EP/BP - Iron (Fe) ≤10 ppm
EP/BP - Loss on Orying ≤0.5%
EP/BP - Ash (sulfated) ≤0.1%
JP - Assay (C6H9N302) (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 - Iron (Fe) ≤10 ppm
JP - Identification Passes Test
JP - Loss on Orying at 105 °C ≤0.30%
JP- 0ptical Rotation [A)2°AO (+) 11.8 - 12.8°
JP - Related Substances Passes Test
JP - pH 7.0 - 8.5
JP - Residue on Ignition ≤0.1%
JP - Sulfate (S04) ≤0.028%
ChP - Assay (dried basis) 99.0 - 101.0%
ChP -Specific Rotation @ 20 °C (+) 12.0 - 12.8°
ChP - Identification 1 (TLC) Passes Test
ChP - Identification 2 (IR) Passes Test
ChP - Acidity or alkalinity (pH) 7.0 - 8.5
ChP - Transmittance of solution ≥ 98.0%
ChP - Chlorides ≤0.02%
ChP - Sulfates ≤0.02%
ChP - Ammonium ≤0.02%
ChP - 0ther amino acids (TLC)(<=0.5%, one spot only) Passes Test
ChP - Loss on drying @ 105 °C ≤0.2%
ChP - Residue on ignition ≤0.1%
ChP - Iron ≤0.001%
ChP - Heavy metals ≤0.001%
ChP - Arsenic ≤0.0001%
ChP - Bacterial endotoxin, EU/g ≤6.0

 

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