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817058 Maleic acid

Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaChemical FormulaMolar MassGrade Value
110-16-7203-742-5C₄H₄O₄HOOCCH=CHCOOH116.07 g/molPh Eur,NF

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      Description
      Catalogue Number817058
      Synonymscis-Butenedioic acid
      DescriptionMaleic acid suitable for use as excipient
      References
      Product Information
      CAS number110-16-7
      EC index number607-095-00-3
      EC number203-742-5
      GradePh Eur,NF
      Hill FormulaC₄H₄O₄
      Chemical formulaHOOCCH=CHCOOH
      Molar Mass116.07 g/mol
      HS Code2917 19 90
      Structure formula ImageStructure formula Image
      Quality LevelMQ500
      Applications
      Biological Information
      Physicochemical Information
      Density1.59 g/cm3 (20 °C)
      Melting Point130 - 135 °C
      pH value1.3 (100 g/l, H₂O, 20 °C)
      Vapor pressure<0.1 hPa (20 °C)
      Bulk density750 - 800 kg/m3
      Solubility478.8 g/l
      Dimensions
      Materials Information
      Toxicological Information
      LD 50 oralLD50 Rat 708 mg/kg
      LD 50 dermalLD50 Rabbit 1560 mg/kg
      Safety Information according to GHS
      Hazard Pictogram(s) Hazard Pictogram(s)
      Hazard Pictogram(s)
      Hazard Statement(s)H302 + H312: Harmful if swallowed or in contact with skin.
      H314: Causes severe skin burns and eye damage.
      H317: May cause an allergic skin reaction.
      H335: May cause respiratory irritation.
      Precautionary Statement(s)P260: Do not breathe dust.
      P271: Use only outdoors or in a well-ventilated area.
      P280: Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection.
      P301 + P312: IF SWALLOWED: Call a POISON CENTER/doctor if you feel unwell.
      P303 + P361 + P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
      P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
      Signal WordDanger
      RTECSOM9625000
      Storage class8A Combustible, corrosive hazardous materials
      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
      Categories of dangerharmful, irritant, sensitizing
      Product Usage Statements
      Storage and Shipping Information
      StorageStore at +15°C to +25°C.
      Packaging Information
      Transport Information
      Declaration (railroad and road) ADR, RIDUN 3261 , 8, II
      Declaration (transport by air) IATA-DGRUN 3261 , 8, II
      Declaration (transport by sea) IMDG-CodeUN 3261 , 8, II, Segregation Group: 1 (Acids)
      Supplemental Information
      Specifications
      Assay (calc.on anhydrous substance)99.0 - 101.0 %
      Assay (HPLC, calc. on anhydrous substance)98.0 - 102.0 %
      Identity (wet chemistry)passes test
      Identity (HPLC)passes test
      Identity (pH)passes test
      Identity (TLC)passes test
      Identity (IR)passes test
      Appearance of solutionpasses test
      Fe (Iron)≤ 5 ppm
      V (Vanadium)*≤ 1 ppm
      Fumaric acid (TLC)≤ 1.5 %
      Fumaric acid (HPLC)≤ 1.0 %
      Malic acid (HPLC)≤ 0.5 %
      Residual solvents (ICH Q3C)excluded by the production process
      Sulfated ash≤ 0.1 %
      Water (K. F.)≤ 0.5 %
      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
      Global Trade Item Number
      Catalogue Number GTIN
      8170581000 04022536548777

      Documentation

      Material Qualification Dossier

      TitleVersion
      8.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Maleic acid SDS

      Title

      Safety Data Sheet (SDS) 

      Maleic acid Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      8170581000 PDF Specification Document

      Certificates

      Title

      Related Products & Applications

      Categories

      Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > pH Adjustment
      Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Acidulants and pH Adjustments
      Reagents, Chemicals and Labware > Organic Synthesis > Organic Synthesis Product Groups > Carboxylic Acids > Di-and Polycarboxylic Acids
      Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > pH Adjustments and Isotonizers
      Reagents, Chemicals and Labware > Organic Synthesis > Organic Synthesis Products for Pharma > Organic Synthesis Building Blocks and Reagents for Pharma > Carboxylic Acids > Di-and Polycarboxylic Acids
      Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > pH Adjustments and Isotonizers