101565 L-Asparagine monohydrate

101565
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      Overview

      Replacement Information

      Key Specifications Table

      CAS #EC NumberHill FormulaMolar MassGrade Value
      5794-13-8 200-735-9 C₄H₈N₂O₃ * H₂O 150.14 g/mol Ph Eur

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      1015651000
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          Plastic bottle 1 kg
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          1015655000
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              Plastic drum 5 kg
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              1015659010
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                  Plastic drum 10 kg
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                  Description
                  Catalogue Number101565
                  SynonymsAsparaginic acid semiamide, Asn
                  References
                  Product Information
                  CAS number5794-13-8
                  EC number200-735-9
                  GradePh Eur
                  Hill FormulaC₄H₈N₂O₃ * H₂O
                  Molar Mass150.14 g/mol
                  HS Code2924 19 00
                  Structure formula ImageStructure formula Image
                  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 +5°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
                  Identity (loss on drying)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
                  Spec. rotation (α 20/D, 100 g/l, hydrochloric acid 3 mol/l, calc. on dried substance)+33.7 to +36.0
                  pH (20 g/l, CO₂-free water)4.0 - 6.0
                  Chloride (Cl)≤ 200 ppm
                  Sulfate (SO₄)≤ 200 ppm
                  Fe (Iron)≤ 10 ppm
                  NH₄ (Ammonium)≤ 0.1 %
                  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 %
                  Ethanol (HS-GC)≤ 5000 ppm
                  Other residual solvents (ICH Q3C)excluded by manufacturing process
                  Sulfated ash (600 °C)≤ 0.1 %
                  Loss on drying (130 °C, 3 h)10.5 - 12.5 %
                  Bacterial endotoxins≤ 3.0 I.U./g
                  Microbiological test (total aerobic microbial count (TAMC))≤ 100 CFU/g
                  Microbiological test (total yeast and mould count (TYMC))≤ 100 CFU/g
                  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.

                  Documentation

                  Material Qualification Dossier

                  Title

                  Quality Management Dossier

                  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
                  1015655000 Plastic drumPDF Specification Document
                  1015659010 Plastic drumPDF Specification Document

                  Certificates

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                  Related Products & Applications

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                  Categories

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                  Biopharmaceutical Manufacturing > Upstream Processing > Cell Culture > Cell Culture Ingredients and Supplements > Cell Culture Ingredients > Amino Acids
                  Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Ingredients - Liquid
                  Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Ingredients - Semi Solid