Product Information
Applications
Biological Information
Physicochemical Information
Density1.49 g/cm3 (20 °C)
Melting Point256 - 268 °C (decomposition)
pH value3.5 - 4.5 (100 g/l, H₂O, 20 °C)
Vapor pressure<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 +5°C to +30°C.
Packaging Information
Transport Information
Supplemental Information
Specifications
Assay (alkalimetric, calculated on dried substance)99.0 - 101.0 %
Assay (Perchloric acid titration, calc. on anhydrous substance)99.0 - 101.0 %
Identity (IR-spectrum)passes test
Identity (Chloride)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
pH (50 g/l CO₂-free water)3.0 - 5.0
pH (100 g/l, CO₂-free 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 anhydrous substance)+9.2 to +10.6
Sulfate (SO₄)≤ 200 ppm
Heavy metals (as Pb)≤ 10 ppm
Fe (Iron)≤ 10 ppm
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 %
Water (according to Karl Fischer)7.2 - 10.0 %
Bacterial endotoxins≤ 20 I.U./g
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, JP

Documentation

Material Qualification Dossier

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Quality Management Dossier

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Operational Excellence Dossier

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L-Histidine monohydrochloride monohydrate SDS

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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 > Surfactants and Stabilizers
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Ingredients - Liquid
Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > pH Adjustments and Isotonizers