Miconazole Nitrate

Miconazole Nitrate is a powder used in oral, rectal, and topical applications. It functions as an anti-fungal agent, commonly included in creams, powders, sprays, and suppositories. This compound is effective in treating fungal infections, offering broad-spectrum activity for various topical and systemic fungal conditions.

Chemical Name: Miconazole Nitrate

CAS Number: 22832-87-7

Dosage Form: Creams, Powder & Powder Blends, Spray, Suppositories

Labeling Claims: Listed in California Prop 65

    Enhanced TDS

    Identification & Functionality

    Features & Benefits

    Applications & Uses

    Properties

    Physical Form
    Appearance
    White or almost white powder, Solution S should be clear and not more intensely colored than reference solution Y7
    Slightly Soluble in
    Water, Ethanol (96%)
    Sparingly soluble in
    Methanol
    Related Substances
    ValueUnitsTest Method / Conditions
    Impurity C Contentmax. 0.2%High-Performance Liquid Chromatography
    Sum of Impurities F & G Contentmax. 0.2%High-Performance Liquid Chromatography
    Unspecified Impurity Contentmax. 0.10%High-Performance Liquid Chromatography
    Total Impurities Contentmax. 0.5%High-Performance Liquid Chromatography
    Residual Solvents
    ValueUnitsTest Method / Conditions
    Methanol Contentmax. 3000ppm-
    Dichloromethane Contentmax. 600ppm-
    Toluene Contentmax. 890ppm-
    Specifications
    ValueUnitsTest Method / Conditions
    Melting Point (range between beginning and end of melting does not exceed 2°C)178 - 184°C-
    Optical Rotation (determined on solution S)-0.10 to +0.10°-
    Sulphated Ash Contentmax. 0.1%-
    Loss on Dryingmax. 0.5%-
    Assay (on dried basis)99 - 101%-
    Particle Size (0.9)max. 20μm-

    Regulatory & Compliance