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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(s) (1H2) 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 Image
                  Applications
                  ApplicationL-Asparagine monohydrate suitable for use as excipient EMPROVE® exp Ph Eur. CAS 5794-13-8, pH 4.0 - 5.5 (20 g/l, H₂O, 20 °C). MSDS and product info below.
                  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 water endangering
                  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
                  Appearancewhite to almost white crystalline powder or colorless crystals
                  Appearance of solution (20 g/l, CO₂-free water)clear and colorless
                  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
                  Sulphate (SO₄)≤ 200 ppm
                  Heavy metals (as Pb)≤ 10 ppm
                  Fe (Iron)≤ 10 ppm
                  NH₄ (Ammonium)≤ 0.1 %
                  Aspartic acid≤ 0.5 %
                  Ninhydrin - positive substances (TLC) (Glutamic acid)≤ 0.5 %
                  Ninhydrin - positive substances (TLC) (any other impurity)≤ 0.5 %
                  Residual solvents (Ph.Eur./ICH) class 3 (Ethanol)≤ 0.5 %
                  Other residual solvents (Ph Eur/ICH)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
                  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

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                  Quality Management Dossier

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                  Operational Excellence Dossier

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                  SDS

                  Title

                  Safety Data Sheet (SDS) 

                  Certificates of Analysis

                  Product Number PackagingSpecificationLot Number
                  1015651000 Plastic bottlePDF Specification Document
                  1015655000 Plastic Drum(s) (1H2)PDF Specification Document
                  1015659010 Plastic drumPDF Specification Document

                  Certificates

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                  Categories

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