104354 L-Histidine monohydrochloride monohydrate

104354
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      Overview

      Replacement Information

      Key Specifications Table

      CAS #EC NumberHill FormulaMolar MassGrade Value
      5934-29-2 211-438-9 C₆H₁₀ClN₃O₂ * H₂O 209.63 g/mol Ph Eur,BP,JP

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      1043540001
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          Plastic bottle 3 x 500 g
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          1043540500
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              Plastic bottle 500 g
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              1043549010
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                  Plastic drum 10 kg
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                  Description
                  Catalogue Number104354
                  SynonymsHis
                  References
                  Product Information
                  CAS number5934-29-2
                  EC number211-438-9
                  GradePh Eur,BP,JP
                  Hill FormulaC₆H₁₀ClN₃O₂ * H₂O
                  Molar Mass209.63 g/mol
                  HS Code2933 29 90
                  Structure formula ImageStructure formula Image
                  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)98.5 - 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))≤ 1E+02 CFU/g
                  Microbiological test (total yeast and mould count (TYMC))≤ 1E+01 CFU/g
                  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

                  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

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                  Categories

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