Pseudoephedrine HCl USP

Pseudoephedrine HCl USP is a powder that is soluble in both alcohol and water. It is commonly used in over-the-counter (OTC) pharmaceutical formulations for its decongestant properties, providing relief from nasal congestion and related symptoms.

Chemical Name: Pseudoephedrine Hydrochloride

Chemical Inventories: AICS (Australia), DSL (Canada), EINECS (EU), NZIoC (New Zealand), TCSI (Taiwan), TSCA (USA)

Certifications & Compliance: DEA Licensed, United States Pharmacopeia (USP)

    Enhanced TDS

    Identification & Functionality

    Chemical Name
    Industry
    Pharma & Nutraceuticals Functions
    Molecular formula
    (C₁₀H₁₅NO)·HCl
    Technologies
    Product Families
    Chemical Structure

     - 1

    Applications & Uses

    Properties

    Physical Form
    Soluble In
    Appearance
    Fine white to off white crystals
    Odor
    Faint characteristic odor
    Soluble in
    Water, Ethanol (95%)
    Slightly Soluble in
    Chloroform
    Typical Properties
    ValueUnitsTest Method / Conditions
    Molecular Weight201.69--
    Residual Solvents
    ValueUnitsTest Method / Conditions
    Acetone Contentmax. 1000ppmHead space Gas chromatography
    Toluene Contentmax. 100ppmHead space Gas chromatography
    Specifications
    ValueUnitsTest Method / Conditions
    Melting Point (range between beginning and end of melting does not exceed 2°C)182 - 186°C-
    Loss on Drying (at 105°C, for 3 hrs)max. 0.5%w/w-
    Specific Optical Rotation (at 24.5 - 25.5°C, 50 mg per ml in water)61 - 62.5°-
    pH Value (50 mg/ml)4.6 - 6--
    Residue on Ignitionmax. 0.1%w/w-
    Assay (on dried basis)99 - 101%w/wPotentiometry
    Impurities
    ValueUnitsTest Method / Conditions
    I-Ephedrine HCl Content (individual specified impurities)max. 0.1%w/wHigh-Performance Liquid Chromatography
    Acetylephedrine Content (individual specified impurities)max. 0.1%w/wHigh-Performance Liquid Chromatography
    Benzaldehyde Content (individual specified impurities)max. 0.1%w/wHigh-Performance Liquid Chromatography
    Individual Unspecified Impurities Contentmax. 0.1%w/wHigh-Performance Liquid Chromatography
    Total Unspecified Impurities Contentmax. 0.2%w/wHigh-Performance Liquid Chromatography
    Total Impurities Contentmax. 0.4%w/wHigh-Performance Liquid Chromatography

    Regulatory & Compliance

    Certifications & Compliance
    Chemical Inventories
    FDA Disclaimer

    These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.