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105357 L-Isoleucine

EMPROVE® EXPERT Ph Eur,JP,USP

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

Synonyms: iso-Leucine, Ile

CAS #: 73-32-5 EC Number: 200-798-2 Molar Mass: 131.17 g/mol Hill Formula: C₆H₁₃NO₂ Grade: Ph Eur,JP,USP
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105357
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
73-32-5200-798-2C₆H₁₃NO₂131.17 g/molPh Eur,JP,USP

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      Description
      Catalogue Number105357
      Synonymsiso-Leucine, Ile
      References
      Product Information
      CAS number73-32-5
      EC number200-798-2
      GradePh Eur,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
      Density1.207 g/cm3 (20 °C)
      Melting Point285.5 °C (decomposition)
      pH value5.5 - 6.5 (40 g/l, H₂O, 20 °C)
      Bulk density470 kg/m3
      Solubility40 g/l
      Dimensions
      Materials Information
      Toxicological Information
      Safety Information according to GHS
      RTECSNR4705000
      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)98.5 - 101.0 %
      Identity (IR-spectrum)passes test
      Identity (specific rotation)passes test
      Appearancewhite to almost white, crystalline powder or flakes
      Appearance of solution (50 g/l, hydrochloric acid 1 mol/l)clear and not more intense in color than reference solution BY₆
      Spec. rotation (α 20/D, 40 g/l, Hydrochloric acid 250 g/l, calc. on dried substance)+40.0 to +43.0
      Spec. rotation (α 20/D, 40 g/l, hydrochloric acid 6 mol/l,previously dried substance)+39.5 to +41.5
      Spec. rotation (α 25/D, 40 g/l, hydrochloric acid 6 mol/l, calc. on dried substance)+38.9 to +41.8
      pH (10 g/l, CO₂-free water)5.5 - 6.5
      Chloride (Cl)≤ 200 ppm
      Sulfate (SO₄)≤ 200 ppm
      Heavy metals (as Pb)≤ 20 ppm
      Fe (Iron)≤ 10 ppm
      Mn (Manganese)≤ 25 ppm
      As (Arsenic)≤ 2 ppm
      Related Compounds, total (TLC)≤ 0.5 %
      Related substances (TLC)passes test
      Related compounds (HPLC) (Leucine)≤ 0.5 %
      Related compounds (HPLC) (Any unspecified impurity)≤ 0.2 %
      Related compounds (HPLC) (Total unspecified impurities)≤ 1.0 %
      Ninhydrin-positive substances (LC) (impurity A (570 nm))≤ 0.3 %
      Ninhydrin-positive substances (LC) (impurity C (570 nm))≤ 0.3 %
      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 %
      Methanol (HS-GC)≤ 3000 ppm
      Other residual solvents (ICH Q3C)excluded by manufacturing process
      Sulfated ash (600 °C)≤ 0.1 %
      Loss on drying (105 °C; 3 h)≤ 0.30 %
      Bacterial endotoxins≤ 10.0 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
      1053571000 04022536906898

      Documentation

      Material Qualification Dossier

      TitleVersion
      9.1

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      L-Isoleucine SDS

      Title

      Safety Data Sheet (SDS) 

      L-Isoleucine Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      1053571000 Plastic bottlePDF Specification Document

      Certificates

      Title