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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
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

Products

Catalogue NumberPackaging Qty/Pack
1.05357.1000 Plastic bottle 1 kg
1.05357.9010 Plastic drum 10 kg
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
1.05357.1000 04022536906898
1.05357.9010 04022536906904

Documentation

Material Qualification Dossier

TitleVersion
10.1

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
1.05357.1000 Plastic bottlePDF Specification Document
1.05357.9010 Plastic drumPDF Specification Document

Certificates

Title