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107430 L-Proline

EMPROVE® EXPERT Ph Eur,JP,USP

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

Synonyms: Pro

CAS #: 147-85-3 EC Number: 205-702-2 Molar Mass: 115.13 g/mol Hill Formula: C₅H₉NO₂ Grade: Ph Eur,JP,USP
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107430
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
147-85-3205-702-2C₅H₉NO₂115.13 g/molPh Eur,JP,USP

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      Description
      Catalogue Number107430
      SynonymsPro
      References
      Product Information
      CAS number147-85-3
      EC number205-702-2
      GradePh Eur,JP,USP
      Hill FormulaC₅H₉NO₂
      Molar Mass115.13 g/mol
      HS Code2933 99 19
      Structure formula ImageStructure formula Image
      Quality LevelMQ500
      Applications
      Biological Information
      Physicochemical Information
      Density1.4 g/cm3 (45 °C)
      Melting Point221 °C (decomposition)
      pH value5 - 7 (100 g/l, H₂O, 20 °C)
      Bulk density500 kg/m3
      Solubility1500 g/l
      Dimensions
      Materials Information
      Toxicological Information
      LD 50 oralLD50 Rat > 5110 mg/kg
      Safety Information according to GHS
      RTECSTW3584000
      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)99.0 - 101.0 %
      Identity (IR-spectrum)passes test
      Identity (specific rotation)passes test
      Appearancewhite or almost white, crystalline powder or colorless crystals
      Appearance of solution (50 g/l; water)clear and colorless
      Appearance of solution (100 g/l, water)clear and colorless
      pH (100 g/l, CO₂-free water)5.9 - 6.9
      Spec. rotation (α 20/D, 40 g/l, water, calc. on dried substance)-84.0 to -86.0
      Spec. rotation (α 25/D, 40 g/l, water, calc. on dried substance)-84.3 to -86.3
      Chloride (Cl)≤ 200 ppm
      Sulfate (SO₄)≤ 200 ppm
      Heavy metals (as Pb)≤ 10 ppm
      Fe (Iron)≤ 10 ppm
      Mn (Manganese)≤ 25 ppm
      Zn (Zinc)≤ 130 ppm
      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 %
      Related substances (LC)≤ 0.1 %
      Residual solvents (ICH Q3C)excluded by manufacturing process
      Sulfated ash (600 °C)≤ 0.1 %
      Loss on Drying (105 °C)≤ 0.3 %
      Bacterial endotoxins≤ 5 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
      1.07430.1000 04022536906928

      Documentation

      Material Qualification Dossier

      TitleVersion
      9.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      L-Proline SDS

      Title

      Safety Data Sheet (SDS) 

      L-Proline Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      1.07430.1000 Plastic bottlePDF Specification Document

      Certificates

      Title

      Brochure

      Title
      バイオ医薬品製造用製品ガイド