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101565 L-Asparagine monohydrate

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,NF

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1015651000
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      1015655000
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          1015659010
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              Description
              Catalogue Number101565
              SynonymsAsparaginic acid semiamide, Asn
              References
              Product Information
              CAS number5794-13-8
              EC number200-735-9
              GradePh Eur,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 +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
              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, 10 g/l, hydrochloric acid 6 mol/l, calc. on dried substance)+33.0 to +36.5
              Chloride (Cl)≤ 200 ppm
              Sulfate (SO₄)≤ 200 ppm
              Fe (Iron)≤ 10 ppm
              Pb (Lead)≤ 5 ppm
              NH₄ (Ammonium)≤ 0.1 %
              Chromatographic purity (TLC) (single impurity)≤ 0.5 %
              Chromatographic purity (TLC) (total impurities)≤ 1.0 %
              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)11.5 - 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., NF

              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

              Title

              Related Products & Applications

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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 Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Ingredients - Liquid
              Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Ingredients - Semi Solid