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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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1043540001
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      1043540500
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          1043549010
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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
              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

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              Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Ingredients - Liquid
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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