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108378 L-Tyrosine

Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
60-18-4200-460-4C₉H₁₁NO₃181.19 g/molPh Eur,ChP,JP,USP

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1.08378.1000
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      Description
      Catalogue Number108378
      Synonyms4-Hydroxyphenylalanine, Tyr
      References
      Product Information
      CAS number60-18-4
      EC number200-460-4
      GradePh Eur,ChP,JP,USP
      Hill FormulaC₉H₁₁NO₃
      Molar Mass181.19 g/mol
      HS Code2922 50 39
      Structure formula ImageStructure formula Image
      Quality LevelMQ500
      Applications
      Biological Information
      Physicochemical Information
      Density1.46 g/cm3
      Melting Point343 °C (decomposition)
      pH value6.5 (0.1 g/l, H₂O)
      Bulk density300 kg/m3
      Solubility0.38 g/l
      Dimensions
      Materials Information
      Toxicological Information
      LD 50 oralLD50 Rat > 5110 mg/kg
      Safety Information according to GHS
      RTECSYP2275600
      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 (perchloric acid titration, calculated on dried substance)99.0 - 101.0 %
      Identity (IR-spectrum)passes test
      Identity (specific rotation)passes test
      Identity (TLC)passes test
      Identity (UV/VIS-Spectrum)passes test
      Appearancewhite to almost white, crystalline powder or colorless crystals
      Appearance of solution (25 g/l, Hydrochloric acid 2 mol/l)clear and not more intense in color than reference solution Y₇
      Appearance of solution (50 g/l, hydrochloric acid 1 mol/l)clear and colorless
      Transmittance of solution (50 g/l, hydrochloric acid 1 mol/l)≥ 95.0 %
      Spec. rotation (α 20/D, 50 g/l, hydrochloric acid 1 mol/l, calc. on dried substance)-12.1 to -11.3
      Spec. rotation (α 20/D, 50 g/l, hydrochloric acid 1 mol/l, previously dried substance)-12.5 to -10.5
      Spec. rotation (α 25/D, 50 g/l, hydrochloric acid 1 mol/l, calc. on dried substance)-11.2 to -9.8
      Acidity (0,2 g/l, CO2 free water)5.0 - 6.5
      Chloride (Cl)≤ 200 ppm
      Sulfate (SO₄)≤ 200 ppm
      Heavy metals (as Pb)≤ 10 ppm
      As (Arsenic)≤ 1 ppm
      Fe (Iron)≤ 10 ppm
      Other amino acids (TLC)≤ 0.4 %
      Related Compounds, total (TLC)≤ 0.5 %
      Related substances (TLC)passes test
      Ninhydrin-positive substances (LC) (impurity A (570 nm))≤ 0.5 %
      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)≤ 0.6 %
      Residual solvents (ICH (Q3C))excluded by manufacturing process
      Sulfated ash (600 °C)≤ 0.1 %
      Loss on drying (105 °C; 3 h)≤ 0.2 %
      Bacterial endotoxins≤ 20 I.U./g
      Microbiological test (total aerobic microbial count (TAMC))≤ 10²
      Microbiological test (total yeast and mould count (TYMC))≤ 10²
      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., ChP, JP, USP
      Global Trade Item Number
      Catalogue Number GTIN
      1.08378.1000 04022536906980

      Documentation

      Material Qualification Dossier

      TitleVersion
      9.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      L-Tyrosine SDS

      Title

      Safety Data Sheet (SDS) 

      L-Tyrosine Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      1.08378.1000 Plastic bottlePDF Specification Document

      Certificates

      Title