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104354 L-Histidine monohydrochloride monohydrate

EMPROVE® EXPERT Ph Eur,BP,ChP,JP

L-Histidine monohydrochloride monohydrate MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: His

CAS #: 5934-29-2 EC Number: 211-438-9 Molar Mass: 209.63 g/mol Hill Formula: C₆H₁₀ClN₃O₂ * H₂O Grade: Ph Eur,BP,ChP,JP
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
5934-29-2211-438-9C₆H₁₀ClN₃O₂ * H₂O209.63 g/molPh Eur,BP,ChP,JP

Products

Catalogue NumberPackaging Qty/Pack
1043540001 Plastic bottle 3 x 500 g
1043540500 Plastic bottle 500 g
1043549010 Plastic drum 10 kg
Description
Catalogue Number104354
SynonymsHis
References
Product Information
CAS number5934-29-2
EC number211-438-9
GradePh Eur,BP,ChP,JP
Hill FormulaC₆H₁₀ClN₃O₂ * H₂O
Molar Mass209.63 g/mol
HS Code2933 29 92
Structure formula ImageStructure formula Image
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Density1.4723 g/cm3 (20 °C)
Melting Point256 - 268 °C (decomposition)
pH value4.38 - 4.48 (149.55 g/l, H₂O, 20 °C)
Vapor pressure<0.1 hPa (20 °C)
Bulk density770 kg/m3
Solubility149.55 g/l
Dimensions
Materials Information
Toxicological Information
Safety Information according to GHS
RTECSMS3119000
Storage class10 - 13 Other liquids and solids
WGKWGK 1 slightly hazardous to water
Disposal3
Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageStore at +2°C to +30°C.
Packaging Information
Transport Information
Supplemental Information
Specifications
Assay (calculated on dried substance)99.0 - 101.0 %
Assay (calc.on anhydrous substance)99.0 - 101.0 %
Identity (IR-spectrum)passes test
Identity (pH)passes test
Identity (wet chemistry)passes test
Identity (specific rotation)passes test
Identity (TLC)passes test
Appearancewhite to almost white crystalline powder or colorless crystals
Appearance of solution (50 g/l CO₂-free water)clear and not more intense in color than reference solution BY₆
Appearance of solution (100 g/l, CO₂-free water)clear and colorless
Transmittance of solution (100 g/l, water)≥ 98.0 %
pH (50 g/l CO₂-free water)3.0 - 5.0
pH (100 g/l, CO₂-free water)3.5 - 4.5
Acidity (100 g/l, water)3.5 - 4.5
Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 120 g/l, calc. on dried substance)+9.2 to +10.6
Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 6 mol/l, calc. on dried substance)+8.5 to +10.5
Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 6 mol/l, calc. on anhydrous substance)+9.2 to +10.6
Chloride (argentometric, calc. on dried substance)16.7 - 17.1 %
Sulfate (SO₄)≤ 200 ppm
Heavy metals (as Pb)≤ 10 ppm
As (Arsenic)≤ 1 ppm
Fe (Iron)≤ 10 ppm
Other amino acids (TLC)≤ 0.2 %
Related substances (TLC)passes test
Ninhydrin-positive substances (LC) (any ninhydrin-positive impurity)≤ 0.2 %
Ninhydrin-positive substances (LC) (ammonium (570 nm))≤ 0.02 %
Ninhydrin-positive substances (LC) (total impurities)≤ 0.5 %
Residual solvents (ICH (Q3C))excluded by manufacturing process
Sulfated ash (600 °C)≤ 0.1 %
Loss on drying (150 °C)7.0 - 10.0 %
Loss on drying (105 °C; 3 h)≤ 0.2 %
Water (according to Karl Fischer)7.2 - 10.0 %
Bacterial endotoxins≤ 20 I.U./g
Bacterial endotoxins (ChP)< 6.0
Microbiological test (total aerobic microbial count (TAMC))≤ 10²
Microbiological test (total yeast and mould count (TYMC))≤ 10¹
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Corresponds to Ph. Eur., BP, ChP, JP
Global Trade Item Number
Catalogue Number GTIN
1043540001 04027269368289
1043540500 04022536050348
1043549010 04022536732657

Documentation

Material Qualification Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

L-Histidine monohydrochloride monohydrate SDS

Title

Safety Data Sheet (SDS) 

L-Histidine monohydrochloride monohydrate Certificates of Analysis

Product Number PackagingSpecificationLot Number
1043540001 Plastic bottlePDF Specification Document
1043540500 Plastic bottlePDF Specification Document
1043549010 Plastic drumPDF Specification Document

Certificates

Title

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Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Ingredients - Liquid
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Ingredients - Liquid
Biopharmaceutical Manufacturing > Upstream Processing > Cell Culture > Cell Culture Ingredients and Supplements > Cell Culture Ingredients > Amino Acids
Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > pH Adjustments and Isotonizers
Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Surfactants and Stabilizers
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > pH Adjustments and Isotonizers
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Surfactants and Stabilizers