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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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                  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
                  1043549010 04022536732657
                  CO1I1043540500 04061839010949
                  CO1I1043549010 04061839010956

                  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
                  1043549010 Plastic drumPDF Specification Document
                  CO1I1043540500 PDF Specification Document
                  CO1I1043549010 PDF 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