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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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104354
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Key Spec Table

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

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      1.04354.9010
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          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
          1.04354.0500 04022536050348
          1.04354.9010 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
          1.04354.0500 Plastic bottlePDF Specification Document
          1.04354.9010 Plastic drumPDF Specification Document

          Certificates

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