The effect of microbial contaminants on the identity and content of active ingredients in drugs

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DOI: https://doi.org/10.29296/25419218-2019-07-01
Issue: 
7
Year: 
2019

O.V. Gunar, M.V. Roshchina, I.A. Builova, N.G. Sakhno, G.M. Bulgakova Research Center for Examination of Medical Products, Ministry of Health of the Russian Federation; 8, Petrovsky Boulevard, Build. 2, Moscow 127051, Russian Federation

Introduction. To assess the quality and safety of drugs entering the consumer market of the Russian Federation is one of the main tasks of the pharmaceutical industry. Microbial contaminants contained in the drugs and their metabolic products can infect the patient’s body and cause severe pyrogenic reactions. In addition, they are able to influence the ingredients of the drug, causing their decomposition. Objective: to study the effects of microbial contaminants contained in drugs on the identity and content of active ingredients. Material and methods. The investigation objects were four drugs contaminated with various bacteria and fungi; these included sodium picosulfate, darunavir, iohexol, and lidocaine. Isolated microbial contaminants were identified using appropriate selective and differential diagnostic culture media, as well as a Vitek 2 Compact bacterial analyzer. The content of active ingredients in the drugs was determined by high performance liquid chromatography and UV spectrophotometry. Results. The analyzed drugs were contaminated with mold fungi, Bacillus circulans, and Burkholderia cepacia. After 24-month storage in sodium picosulfate and lidocaine, the content of the microorganisms did not change; the quantity of molds contained in darunavir tablets decreased by 4 times and that of Burkholderia cepacia in injectable Yogexol solution increased by 900 times. The microorganisms present in the drugs did not affect the identity and content of active ingredients. Conclusion. Preservation of the viability of the microorganisms identified in the test drugs for 24 months of storage was studied. The effects of microorganisms on the quality indicators of these drugs were not established.
Keywords: 
drugs
microbial contaminants
identity
content of active ingredients
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