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Microcount method for petrolatum-based topical ointments containing waxes.

K Tsuji, J H Robertson

    Applied Microbiology
    |November 1, 1970
    PubMed
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    A new solvent system effectively detects microorganisms in topical ointments. This method is less toxic than heat-sterilized alternatives, ensuring reliable microbial analysis.

    Area of Science:

    • Microbiology
    • Pharmaceutical Science
    • Analytical Chemistry

    Background:

    • Topical ointments require microbial detection for safety and efficacy.
    • Existing methods for microbial analysis in ointments can be complex or toxic.

    Purpose of the Study:

    • To develop a practical and less toxic solvent system for detecting microorganisms in topical ointments.
    • To evaluate the efficacy and toxicity of the developed solvent system.

    Main Methods:

    • Dissolving ointment in a specific solvent mixture (isopropyl myristate, carbon disulfide, xylene).
    • Filtering the solution through a 0.45-μm membrane filter.
    • Washing the filter with Brain Heart Infusion broth and Tween 80, followed by incubation on Trypticase Soy Agar.

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    Main Results:

    • The developed solvent system successfully facilitated microorganism detection.
    • Toxicity assessment showed the solvent mixture was less toxic than heat-sterilized isopropyl myristate and comparable to filter-sterilized isopropyl myristate.
    • The method demonstrated effectiveness against various bacteria, including Staphylococcus aureus and Escherichia coli, and Bacillus subtilis spores.

    Conclusions:

    • A practical and effective solvent system for microbial detection in topical ointments has been established.
    • The developed method offers a reduced toxicity profile compared to certain conventional approaches.
    • This technique provides a reliable tool for quality control in pharmaceutical preparations.