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101565 L-Asparagine monohydrate

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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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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
              카탈로그 번호 GTIN
              1.01565.1000 04022536022819
              1.01565.5000 04022536732602
              1.01565.9010 04022536732619

              Documentation

              Material Qualification Dossier

              TitleVersion
              10.0

              Quality Management Dossier (Open Access)

              Title

              Operational Excellence Dossier

              Title

              L-Asparagine monohydrate MSDS

              타이틀

              물질안전보건자료(MSDS) 

              L-Asparagine monohydrate Certificates of Analysis

              제품 번호 패킹스펙로트(lot) 번호
              1.01565.1000 Plastic bottlePDF 사양 문건
              1.01565.5000 Plastic drumPDF 사양 문건
              1.01565.9010 Plastic drumPDF 사양 문건

              Certificates

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              카테고리

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