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Features of Microbiological Analysis of the Quality of Soft Dosage Forms

  • STRUCTURE OF CHEMICAL COMPOUNDS, METHODS OF ANALYSIS AND PROCESS CONTROL
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Pharmaceutical Chemistry Journal Aims and scope

Materials related to features of microbiological analysis of the purity of soft dosage forms are presented. Possible requirements for microbiological quality parameters of various soft dosage forms are analyzed. The applicability of a direct inoculation technique to obtain reliable quantitative determinations of microorganisms is proven using gel, ointment, and suppositories as examples. The accuracy (Kgr 75 – 107%) and intralaboratory precision (CV 2 – 6%) are calculated and fall within the required limits. The specificity of the method is considered for a particular working range established according to recommendations of the RF State Pharmacopoeia, i.e., up to 250 CFU/dish for bacteria and up to 50 CFU/dish for yeasts and molds. Features of microbiological analysis of the quality of patches and transdermal therapeutic systems are studied. The possibilities and limitations of a membrane filtration technique are shown using 83 series of 18 items meeting regulatory requirements as examples.

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ACKNOWLEDGMENTS

The work was performed in the framework of a State Task for SCEEMP, Ministry of Healthcare of Russia, No. 056-00005-21-00 for performing applied research.

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Authors and Affiliations

  1. Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Healthcare of the Russian Federation, 8/2 Petrovskii Blvd, Moscow, 127051, Russia

    O. V. Gunar, G. M. Bulgakova & N. A. Borisova

Authors
  1. O. V. Gunar
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  2. G. M. Bulgakova
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  3. N. A. Borisova
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Correspondence to O. V. Gunar.

Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 55, No. 4, pp. 56 – 59, April, 2021.

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Gunar, O.V., Bulgakova, G.M. & Borisova, N.A. Features of Microbiological Analysis of the Quality of Soft Dosage Forms. Pharm Chem J 55, 392–395 (2021). https://doi.org/10.1007/s11094-021-02433-w

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  • DOI: https://doi.org/10.1007/s11094-021-02433-w

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