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Related Experiment Videos

Particles in small volume injections.

S A Taylor, J Spence

    The Journal of Pharmacy and Pharmacology
    |December 1, 1983
    PubMed
    Summary
    This summary is machine-generated.

    Particulate contamination in small volume injections was assessed using light blockage (HIAC) and electrical sensing zone (Coulter counter) methods. HIAC proved more suitable, revealing significant particle count discrepancies and non-compliance with existing parenteral limits.

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    Area of Science:

    • Pharmaceutical Science
    • Analytical Chemistry
    • Quality Control

    Background:

    • Particulate contamination is a critical quality attribute for injectable pharmaceuticals.
    • Existing pharmacopoeial limits for large volume parenterals may not be appropriate for small volume injections.

    Purpose of the Study:

    • To evaluate and compare the suitability of light blockage (HIAC) and electrical sensing zone (Coulter counter) techniques for enumerating particles in small volume injections.
    • To assess the level of particulate contamination in small volume injections against established pharmacopoeial standards.

    Main Methods:

    • Comparative analysis of two particle counting techniques: HIAC (light blockage) and Coulter counter (electrical sensing zone).
    • Examination of particulate contamination in multiple batches of small volume injections.

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  • Assessment of particle count data against British Pharmacopoeia limits for large volume parenterals.

    • Main Results:

    • The HIAC system demonstrated greater suitability for quantifying particles in small volume injections compared to the Coulter counter.
    • Significant and variable differences in particle counts were observed between the two methods, particularly for particles smaller than 5 microns.
    • All examined small volume injections failed to meet the British Pharmacopoeia's particulate limits for large volume parenterals.

    Conclusions:

    • The HIAC method is recommended for assessing particulate contamination in small volume injections.
    • Current British Pharmacopoeia limits for large volume parenterals are inadequate for small volume injections.
    • Further development of specific particulate limits for small volume injections is warranted.