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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

Pricing & Availability

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8170581000
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      1 kg
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      8170589025
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          Fibre carton 25 kg
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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
          8170589025 04022536648118

          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
          8170589025 Fibre cartonPDF Specification Document

          Certificates

          Title

          Related Products & Applications

          Categories

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          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