Maleic Acid

Maleic Acid is used in oral applications, particularly in orally disintegrating tablets (ODTs), where it functions as a buffering agent and pH stabilizer. It helps maintain the proper acidity or alkalinity of formulations, ensuring their stability and enhancing the effectiveness of oral medications. This compound is essential in optimizing the performance of pharmaceutical products.

Chemical Name: Maleic acid

Functions: Buffering Agent

CAS Number: 110-16-7

Labeling Claims: Not Listed In California Proposition 65

Certifications & Compliance: FDA 40 CFR 122.21, FDA 40 CFR 122.42, REACH (Europe)

Dosage Form: Orally Disintegrating Tablets (ODTs)

Synonyms: (2Z)-2-Butenedioic acid, (2Z)-Butene-2-dioic acid, (Z)-2-Butenedioic acid, 2-Butenedioic acid (2Z)-, 2-Butenedioic acid (Z)-, cis-1,2-Ethylenedicarboxylic acid, cis-2-Butenedioic acid, cis-Butenedioic acid, Maleinic acid, Malezid CM, Toxilic acid

    Enhanced TDS

    Identification & Functionality

    Chemical Family
    Chemical Name
    Industry
    Pharma & Nutraceuticals Functions
    Molecular formula
    C₄H₄O₄
    Technologies
    Product Families

    Features & Benefits

    Applications & Uses

    Properties

    Appearance
    White crystalline powder
    Soluble in
    Water
    Characteristics
    ValueUnitsTest Method / Conditions
    Assay99.0 - 101.0%-
    Fumaric Acid Contentmax. 0.1%-
    Melting Point132 - 135°C-
    Residue on Ignitionmax. 0.10%-
    Water Contentmax. 0.10%Karl Fischer
    Heavy Metals
    ValueUnitsTest Method / Conditions
    Heavy Metal Content (Lead)max. 10ppm-
    Iron Contentmax. 5ppm-

    Regulatory & Compliance