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101700 L-Alanine

EMPROVE® EXPERT Ph Eur,ChP,JP,USP

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

Synonyms: 2-Aminopropionic acid, Ala

CAS #: 56-41-7 EC Number: 200-273-8 Molar Mass: 89.09 g/mol Hill Formula: C₃H₇NO₂ Grade: Ph Eur,ChP,JP,USP
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101700
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
56-41-7200-273-8C₃H₇NO₂89.09 g/molPh Eur,ChP,JP,USP

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1017001000
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      		 Plastic bottle 1 kg
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      1017009010
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          Description
          Catalogue Number101700
          Synonyms2-Aminopropionic acid, Ala
          References
          Product Information
          CAS number56-41-7
          EC number200-273-8
          GradePh Eur,ChP,JP,USP
          Hill FormulaC₃H₇NO₂
          Molar Mass89.09 g/mol
          HS Code2922 49 90
          Structure formula ImageStructure formula Image
          Quality LevelMQ500
          Applications
          Biological Information
          Physicochemical Information
          Density1.432 g/cm3 (22 °C)
          Melting Point314.6 °C (decomposition)
          pH value5.5 - 7.0 (89.1 g/l, H₂O, 25 °C)
          Bulk density660 kg/m3
          Solubility166.5 g/l
          Dimensions
          Materials Information
          Toxicological Information
          Safety Information according to GHS
          RTECSAY2990000
          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 +15°C to +25°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 colorless crystals
          Appearance of solution (25 g/l, water)clear and not more intense in color than reference solution BY₆
          Appearance of solution (100 g/l, water)clear and colorless
          Transmittance of solution (50 g/l, water)≥ 98.0
          Spec. rotation (α 20/D, 50 g/l, hydrochloric acid 1 mol/l, calc. on dried substance)+14.0 to +15.0
          Spec. rotation (α 20/D, 100 g/l, hydrochloric acid 250 g/l, calc. on dried substance)+13.5 to +15.5
          Spec. rotation (α 25/D, 100 g/l, hydrochloric acid 6 mol/l, calc. on dried substance)+13.7 to +15.1
          Spec. rotation (α 20/D, 100 g/l, hydrochloric acid 6mol/l, previously dried substance)+13.5 to +15.5
          pH (50 g/l CO₂-free water)5.7 - 6.7
          Acidity (50 g/l, CO2-free Water)5.5 - 7.0
          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 (HPLC) (maleic acid)≤ 0.05 %
          Related compounds (HPLC) (malic acid)≤ 0.05 %
          Related compounds (HPLC) (fumaric acid)≤ 0.05 %
          Related compounds (HPLC) (Any unspecified impurity)≤ 0.05 %
          Related compounds (HPLC) (Total unspecified impurities)≤ 0.20 %
          Related substances (LC)≤ 0.1 %
          Ninhydrin-positive substances (LC) (any ninhydrin-positive impurity)≤ 0.10 %
          Ninhydrin-positive substances (LC) (ammonium (570 nm))≤ 0.02 %
          Ninhydrin-positive substances (LC) (total impurities)≤ 0.5 %
          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≤ 2.0 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
          1017001000 04022536906768
          1017009010 04022536906775

          Documentation

          Material Qualification Dossier

          TitleVersion
          10.0

          Quality Management Dossier (Open Access)

          Title

          Operational Excellence Dossier

          Title

          Required Licenses

          Title
          PRODUCTO REGULADO POR LA SECRETARÍA DE SALUD

          L-Alanine SDS

          Title

          Safety Data Sheet (SDS) 

          L-Alanine Certificates of Analysis

          Product Number PackagingSpecificationLot Number
          1017001000 Plastic bottlePDF Specification Document
          1017009010 Plastic drumPDF Specification Document

          Certificates

          Title

          User Guides

          Title
          Raw Materials for Biopharmaceutical Manufacturing