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101565 L-Asparagine monohydrate

EMPROVE® EXPERT Ph Eur,ChP,NF

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

Synonyms: Asparaginic acid semiamide, Asn

CAS #: 5794-13-8 EC Number: 200-735-9 Molar Mass: 150.14 g/mol Hill Formula: C₄H₈N₂O₃ * H₂O Grade: Ph Eur,ChP,NF
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101565
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Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
5794-13-8200-735-9C₄H₈N₂O₃ * H₂O150.14 g/molPh Eur,ChP,NF

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      Description
      Catalogue Number101565
      SynonymsAsparaginic acid semiamide, Asn
      References
      Product Information
      CAS number5794-13-8
      EC number200-735-9
      GradePh Eur,ChP,NF
      Hill FormulaC₄H₈N₂O₃ * H₂O
      Molar Mass150.14 g/mol
      HS Code2924 19 00
      Structure formula ImageStructure formula Image
      Quality LevelMQ500
      Applications
      Biological Information
      Physicochemical Information
      Melting Point215 - 217 °C decomposes
      pH value4.0 - 5.5 (20 g/l, H₂O, 20 °C)
      Bulk density530 kg/m3
      Solubility22 g/l
      Dimensions
      Materials Information
      Toxicological Information
      Safety Information according to GHS
      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 %
      Assay (HPLC, calculated on dried substance)95.5 - 102.0 %
      Identity (IR-spectrum)passes test
      Identity (specific rotation)passes test
      Identity (HPLC)passes test
      Identity (loss on drying)passes test
      Identity (wet chemistry)passes test
      Identity (TLC)passes test
      Appearancewhite to almost white crystalline powder or colorless crystals
      Appearance of solution (20 g/l, CO₂-free water)clear and not more intense in color than reference solution B₉
      Transmittance of solution (20 g/l, water)≥ 98.0 %
      pH (20 g/l, CO₂-free water)4.0 - 6.0
      Spec. rotation (α 20/D, 100 g/l, hydrochloric acid 3 mol/l, calc. on dried substance)+33.7 to +36.0
      Spec. rotation (α 20/D, 20 g/l, hydrochloric acid 3 mol/l,calc. on dried substance)+31.0 to +35.0
      Spec. rotation (α 20/D, 10 g/l, hydrochloric acid 6 mol/l, calc. on dried substance)+33.0 to +36.5
      Chloride (Cl)≤ 50 ppm
      Sulfate (SO₄)≤ 50 ppm
      Heavy metals (as Pb)≤ 10 ppm
      As (Arsenic)≤ 1 ppm
      Fe (Iron)≤ 10 ppm
      Pb (Lead)≤ 5 ppm
      NH₄ (Ammonium)≤ 0.1 %
      Other amino acids (TLC)≤ 0.5 %
      Related substances (HPLC) (impurity A)≤ 0.5 %
      Related substances (HPLC) (impurity C)≤ 0.1 %
      Related substances (HPLC) (any unspecified impurity)≤ 0.05 %
      Related substances (HPLC) (total impurities)≤ 0.8 %
      Organic Impurities (HPLC) (Asparagine related compound A (2,2’-(3,6-Dioxopiperazine-2,5-diyl)diacetamide))≤ 1.0 %
      Organic Impurities (HPLC) (Aspartic acid)≤ 1.0 %
      Organic Impurities (HPLC) (any unspecified impurity)≤ 0.5 %
      Organic Impurities (HPLC) (total impurities)≤ 3.0 %
      Ethanol (HS-GC)≤ 5000 ppm
      Other residual solvents (ICH Q3C)excluded by manufacturing process
      Sulfated ash (600 °C)≤ 0.1 %
      Loss on drying (105 °C; 3 h)11.5 - 12.5 %
      Loss on drying (130 °C, 3 h)11.5 - 12.5 %
      Bacterial endotoxins≤ 3.0 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, NF
      Global Trade Item Number
      Catalogue Number GTIN
      1015651000 04022536022819

      Documentation

      Material Qualification Dossier

      TitleVersion
      10.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      L-Asparagine monohydrate SDS

      Title

      Safety Data Sheet (SDS) 

      L-Asparagine monohydrate Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      1015651000 Plastic bottlePDF Specification Document

      Certificates

      Title

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