Codeine Phosphate Hemihydrate

Codeine Phosphate Hemihydrate is a powder used in API manufacturing and oral applications. It functions as an anti-diarrheal agent, helping to reduce symptoms of diarrhea by acting on the digestive system. This compound plays a crucial role in the formulation of therapeutic products for gastrointestinal disorders.

Chemical Name: (1S,5R,13R,14S,17R)-10-Methoxy-4-methyl-12-oxa-4-azapentacyclo[9.6.1.0¹,¹³.0⁵,¹⁷.0⁷,¹⁸]octadeca-7(18),8,10,15-tetraen-14-ol

CAS Number: 41444-62-6

    Enhanced TDS

    Identification & Functionality

    Features & Benefits

    Benefit Claims (Health)

    Applications & Uses

    Properties

    Physical Form
    Appearance
    White or almost white crystalline powder or small colorless crystals
    Microbiological Values
    ValueUnitsTest Method / Conditions
    Total Aerobic Microbial Count0cfu/gPh.Eur. (5.1.4)
    Total Combined Yeasts/Molds Count0cfu/gPh.Eur. (5.1.4)
    Related Substances
    ValueUnitsTest Method / Conditions
    Impurity A Content0.31%High-Performance Liquid Chromatography
    Impurity H Contentmax. 0.05%High-Performance Liquid Chromatography
    Impurity C Contentmax. 0.05%High-Performance Liquid Chromatography
    Impurity D Contentmax. 0.05%High-Performance Liquid Chromatography
    Impurity E Contentmax. 0.05%High-Performance Liquid Chromatography
    Impurity I Contentmax. 0.05%High-Performance Liquid Chromatography
    Unspecified Impurity Content (each relative retention time)max. 0.10%High-Performance Liquid Chromatography
    Total Impurities Content0.36%-
    Residual Solvents
    ValueUnitsTest Method / Conditions
    Ethanol Contentmax. 500ppm-
    Specifications
    ValueUnitsTest Method / Conditions
    Loss on Drying2.3%-
    Actual Acidity4.3--
    Specific Optical Rotation (dried substance)-102 to -98°-
    Sulphate Contentmax. 0.1%-
    Assay (dried substance)100.5%-

    Regulatory & Compliance

    Certifications & Compliance