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105020 L-Leucine

EMPROVE® EXPERT Ph Eur,ChP,JP,USP

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

Synonyms: Leu

CAS #: 61-90-5 EC Number: 200-522-0 Molar Mass: 131.17 g/mol Hill Formula: C₆H₁₃NO₂ Grade: Ph Eur,ChP,JP,USP
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105020
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Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
61-90-5200-522-0C₆H₁₃NO₂131.17 g/molPh Eur,ChP,JP,USP

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      Description
      Catalogue Number105020
      SynonymsLeu
      References
      Product Information
      CAS number61-90-5
      EC number200-522-0
      GradePh Eur,ChP,JP,USP
      Hill FormulaC₆H₁₃NO₂
      Molar Mass131.17 g/mol
      HS Code2922 49 90
      Structure formula ImageStructure formula Image
      Quality LevelMQ500
      Applications
      Biological Information
      Physicochemical Information
      Density1.17 g/cm3 (20 °C)
      Melting Point293 °C (decomposition)
      pH value5.5 - 6.5 (20 g/l, H₂O, 20 °C)
      Vapor pressure<1 hPa (20 °C)
      Bulk density300 - 400 kg/m3
      Solubility18.9 g/l
      Dimensions
      Materials Information
      Toxicological Information
      Safety Information according to GHS
      RTECSOH2850000
      Storage class10 - 13 Other liquids and solids
      WGKWGK 1 slightly hazardous to water
      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)98.5 - 101.0 %
      Identity (IR-spectrum)passes test
      Identity (specific rotation)passes test
      Identity (TLC)passes test
      Appearancewhite to almost white, crystalline powder or shiny flakes
      Appearance of solution (50 g/l; hydrochloric acid 1 mol/l)clear and not more intense in color than reference solution BY₆
      Transmittance of solution (10 g/l, water)≥ 98.0 %
      Spec. rotation (α 20/D, 40 g/l, hydrochloric acid 250 g/l, calc. on dried substance)+14.5 to +16.5
      Spec. rotation (α 25/D, 40 g/l, hydrochloric acid 6 mol/l, calc. on dried substance)+14.9 to +17.3
      Spec. rotation (α 20/D, 40 g/l, hydrochloric acid 6 mol/l, calc. on dried substance)+14.9 to +16.0
      pH (10 g/l, CO₂-free water)5.5 - 6.5
      Acidity (10 g/l, water)5.5 - 6.5
      Chloride (Cl)≤ 200 ppm
      Sulfate (SO₄)≤ 200 ppm
      Heavy metals (as Pb)≤ 10 ppm
      Fe (Iron)≤ 10 ppm
      As (Arsenic)≤ 1 ppm
      Other amino acids (TLC)≤ 0.5 %
      Related Compounds, total (TLC)≤ 0.5 %
      Related substances (TLC)passes test
      Related compounds (HPLC) (Isoleucine)≤ 0.8 %
      Related compounds (HPLC) (Any unspecified impurity)≤ 0.2 %
      Related compounds (HPLC) (Total unspecified impurities)≤ 1.0 %
      Ninhydrin-positive substances (LC) (impurity A (570 nm))≤ 0.8 %
      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)≤ 1.0 %
      Residual solvents (ICH Q3C)excluded by manufacturing process
      Sulfated ash (600 °C)≤ 0.1 %
      Loss on drying (105 °C; 3 h)≤ 0.20 %
      Bacterial endotoxins≤ 3.0 I.U./g
      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., JP, USP
      Global Trade Item Number
      Catalogue Number GTIN
      1.05020.1000 04022536986364

      Documentation

      Material Qualification Dossier

      TitleVersion
      9.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      L-Leucine SDS

      Title

      Safety Data Sheet (SDS) 

      L-Leucine Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      1.05020.1000 Plastic bottlePDF Specification Document

      Certificates

      Title

      Brochure

      Title
      バイオ医薬品製造用製品ガイド