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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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Overview

Replacement Information

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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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,ChP,NF
              Hill FormulaC₄H₈N₂O₃ * H₂O
              Molar Mass150.14 g/mol
              HS Code2924 19 99
              Structure formula ImageStructure formula Image
              Quality LevelMQ500
              Applications
              Biological Information
              Physicochemical Information
              Melting Point235 °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
              1015655000 04022536732602
              1015659010 04022536732619

              Documentation

              Material Qualification Dossier

              TitleVersion
              11.0

              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
              1015655000 Plastic drumPDF Specification Document
              1015659010 Plastic drumPDF Specification Document

              Certificates

              Title

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