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Analysis of the Quality of the Drug Ibuprofen According to the Microbiological-Purity and Particle-Size Indicators

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

Material related to the analysis of the quality according to Microbiological Purity and Particle Size indicators of various dosage forms of ibuprofen drug and substance are presented. Possible regulatory requirements for microbiological quality are analyzed. The drug being studied is shown to affect pharmacopoeial strains of Gram-positive aerobic bacteria (B. subtilis) and yeast (C. albicans) and mold fungi (A. brasiliensis) when seeded on appropriate growth media under conditions for determining microbiological purity. The revealed antimicrobial effect was eliminated by additional dilution, which made it possible to use direct seeding for analysis. The critical quality indicator for ibuprofen suspension was Particle Size, a discrepancy of which was found in drugs for babies up to 1 year and children older than 1 year.

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Authors and Affiliations

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

    O. V. Gunar, A. V. Dorenskaya & G. M. Bulgakova

Authors
  1. O. V. Gunar
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  2. A. V. Dorenskaya
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  3. G. M. Bulgakova
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Corresponding author

Correspondence to O. V. Gunar.

Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 57, No. 6, pp. 53 – 58, June, 2023.

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Gunar, O.V., Dorenskaya, A.V. & Bulgakova, G.M. Analysis of the Quality of the Drug Ibuprofen According to the Microbiological-Purity and Particle-Size Indicators. Pharm Chem J 57, 907–912 (2023). https://doi.org/10.1007/s11094-023-02966-2

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  • DOI: https://doi.org/10.1007/s11094-023-02966-2

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