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[Toxic impurities in chlorhexidine digluconate].

G Kohlbecker

    Deutsche Zahnarztliche Zeitschrift
    |April 1, 1989
    PubMed
    Summary
    This summary is machine-generated.

    Chlorhexidine-digluconate preparations show significant p-chloroaniline contamination, a toxic compound. Storage conditions, especially warmth, increase these toxic levels over time.

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    Area of Science:

    • Analytical Chemistry
    • Pharmaceutical Analysis
    • Toxicology

    Background:

    • Chlorhexidine-digluconate is a widely used antiseptic.
    • Concerns exist regarding toxic contaminants in pharmaceutical preparations.
    • p-Chloroaniline is a known toxic and carcinogenic impurity.

    Purpose of the Study:

    • To develop and apply a novel HPLC method for analyzing chlorhexidine-digluconate purity.
    • To quantify p-chloroaniline and other contaminants in chlorhexidine-digluconate products.
    • To investigate the impact of storage conditions on contaminant levels.

    Main Methods:

    • Development of a high-pressure liquid chromatographic (HPLC) method.
    • Analysis of three chlorhexidine-digluconate preparations.

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  • Storage studies under various light and temperature conditions for six months.

    • Main Results:

    • Found significant variations in p-chloroaniline contamination (1.7-8.5 mmol/mol) between products.
    • Identified other contaminants including p-chlorophenyl-isocyanate and p-chlorophenyl-carbodiimide.
    • Demonstrated a linear increase in p-chloroaniline with storage time, accelerated by higher temperatures (35°C).

    Conclusions:

    • Product quality and contamination levels vary significantly among chlorhexidine-digluconate preparations.
    • Storage temperature is a critical factor influencing the increase of toxic p-chloroaniline.
    • Recommendations for storage and quality control of chlorhexidine-digluconate are suggested to minimize toxic compound formation.