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108378 L-Tyrosine

EMPROVE® EXPERT Ph Eur,ChP,JP,USP

L-Tyrosine MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: 4-Hydroxyphenylalanine, Tyr

CAS #: 60-18-4 EC Number: 200-460-4 Molar Mass: 181.19 g/mol Hill Formula: C₉H₁₁NO₃ Grade: Ph Eur,ChP,JP,USP
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108378
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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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1083781000
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      1083789010
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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
          1083781000 04022536906980
          1083789010 04022536906997

          Documentation

          Material Qualification Dossier

          TitleVersion
          9.0

          Quality Management Dossier (Open Access)

          Title

          Operational Excellence Dossier

          Title

          Required Licenses

          Title
          PRODUCTO REGULADO POR LA SECRETARÍA DE SALUD

          L-Tyrosine SDS

          Title

          Safety Data Sheet (SDS) 

          L-Tyrosine Certificates of Analysis

          Product Number PackagingSpecificationLot Number
          1083781000 Plastic bottlePDF Specification Document
          1083789010 Plastic drumPDF Specification Document

          Certificates

          Title

          User Guides

          Title
          Raw Materials for Biopharmaceutical Manufacturing