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107647 L-Serine

Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
56-45-1200-274-3C₃H₇NO₃105.09 g/molPh Eur,JP,USP

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      Plastic bottle 1 kg
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      Description
      Catalogue Number107647
      Synonyms3-Hydroxy-L-alanine, Ser
      References
      Product Information
      CAS number56-45-1
      EC number200-274-3
      GradePh Eur,JP,USP
      Hill FormulaC₃H₇NO₃
      Molar Mass105.09 g/mol
      HS Code2922 50 00
      Structure formula ImageStructure formula Image
      Quality LevelMQ500
      Applications
      Biological Information
      Physicochemical Information
      Density1.6 g/cm3 (22 °C)
      Melting Point222 °C decomposes
      pH value5 - 6 (100 g/l, H₂O, 20 °C)
      Bulk density570 kg/m3
      Solubility360 g/l
      Dimensions
      Materials Information
      Toxicological Information
      Safety Information according to GHS
      RTECSVT8100000
      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 or colorless, needle-shaped crystals
      Appearance of solution (50 g/l; water)clear and not more intense in color than reference solution BY₆
      Appearance of solution (100 g/l, water)clear and colorless
      Spec. rotation (α 20/D, 100 g/l, hydrochloric acid 2 mol/l, calc. on dried substance)+14.0 to +16.0
      Spec. rotation (α 20/D, 100 g/l, hydrochloric acid 2 mol/l, previously dried substance)+14.0 to +16.0
      Spec. rotation (α 25/D, 100 g/l, hydrochloric acid 2 mol/l, calc. on dried substance)+14.0 to +15.6
      pH (100 g/l, CO₂-free water)5.2 - 6.2
      Chloride (Cl)≤ 200 ppm
      Sulfate (SO₄)≤ 200 ppm
      Heavy metals (as Pb)≤ 10 ppm
      Co (Cobalt)≤ 0.5 ppm
      Cu(Copper)≤ 25 ppm
      Fe (Iron)≤ 10 ppm
      Mn (Manganese)≤ 25 ppm
      Mo (Molybdenum)≤ 2.5 ppm
      Zn (Zinc)≤ 130 ppm
      Related substances (TLC)passes test
      Related Compounds, total (TLC)≤ 0.5 %
      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)≤ 0.5 %
      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)≤ 0.2 %
      Bacterial endotoxins≤ 2.0 I.U./g
      Total aerobic microbial count (TAMC)≤ 10²
      Total combined yeasts/moulds 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., JP, USP.
      Global Trade Item Number
      Catalogue Number GTIN
      1.07647.1000 04022536906959

      Documentation

      Material Qualification Dossier

      TitleVersion
      8.2

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      L-Serine SDS

      Title

      Safety Data Sheet (SDS) 

      L-Serine Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      1.07647.1000 Plastic bottlePDF Specification Document

      Certificates

      Title

      Brochure

      Title
      バイオ医薬品製造用製品ガイド