N-Methyl-D-Glucamine

N-Methyl-D-Glucamine (Meglumine) is a hexosamine derived from D-glucitol, where the hydroxy group at position 1 is substituted by the nitrogen of a methylamino group. It is primarily used as a pH-adjusting and solubilizing agent in solid oral and parenteral formulations. Actylis offers this product manufactured and packed under GMP conditions, with control of elemental impurities. It complies with USP, Ph.Eur, BP, and Ch.P standards, ensuring high-quality standards for use in pharmaceutical applications.

Chemical Name: N-Methyl-D-Glucamine

CAS Number: 6284-40-8

Functions: Solubilizer, pH Stabilizer

Dosage Form: Orally Disintegrating Tablets (ODTs)

Synonyms: 1-Deoxy-1-methylaminosorbitol, Meglumine

    Enhanced TDS

    Identification & Functionality

    Applications & Uses

    Properties

    Characteristics
    ValueUnitsTest Method / Conditions
    Assay (on dry basis)99.0 - 100.5%-
    Loss on Dryingmax. 1%-
    Melting Range128 - 132°C-
    Methanol Contentmax. 3000OM-
    Residue on Ignitionmax. 0.1%-
    Specific Rotation-17.3 to -15.7°-

    Regulatory & Compliance