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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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1053571000
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      		 Plastic bottle 1 kg
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      1053579010
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          		 Plastic drum 10 kg
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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
          1053579010 04022536906904

          Documentation

          Material Qualification Dossier

          TitleVersion
          10.1

          Quality Management Dossier (Open Access)

          Title

          Operational Excellence Dossier

          Title

          Required Licenses

          Title
          PRODUCTO REGULADO POR LA SECRETARÍA DE SALUD

          L-Isoleucine SDS

          Title

          Safety Data Sheet (SDS) 

          L-Isoleucine Certificates of Analysis

          Product Number PackagingSpecificationLot Number
          1053571000 Plastic bottlePDF Specification Document
          1053579010 Plastic drumPDF Specification Document

          Certificates

          Title

          User Guides

          Title
          Raw Materials for Biopharmaceutical Manufacturing