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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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      		 Plastic bottle 500 g
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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
      1043540500 04022536050348

      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
      1043540500 Plastic bottlePDF Specification Document

      Certificates

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      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