The “microbiological purity” criterion is an important quality attribute of non-sterile drugs and excipients in the pharmaceutical industry. The impedance conductometry method of microbiological analysis (ICMMA) is based on monitoring of changes in the impedance (resistance to alternating electric current) of liquid growth medium resulting from the living activity of microorganisms contained in the analyzed sample. The aim of this work was to determine the possibility of using ICMMA for determining the total number (TN) of aerobic microorganisms in natural excipients. As a result, the TNs determined by conductometric and pharmacopoeial two-layer agar methods converged with a correlation coefficient of 0.95. This allowed the conductometric method to be recommended as a routine method for determining the TN of aerobic microorganisms when analyzing the microbiological purity of excipients intended for pharmaceutical production.
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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 56, No. 6, pp. 54 – 58, June, 2022.
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Anan’eva, E.P., Bogdanova, O.Y., Gurina, S.V. et al. Using a Conductometric Method in Microbiological Control of Natural Excipients. Pharm Chem J 56, 872–876 (2022). https://doi.org/10.1007/s11094-022-02721-z
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DOI: https://doi.org/10.1007/s11094-022-02721-z