Abstract
Objective. Determination of the stability of different series of the drug "Piron film-coated tablets, 50 mg", when stored in natural conditions. Materials and methods. Three experimental series of new anti-inflammatory drug Piron tablets were analyzed. The stability study was carried out in accordance with the requirements of the State Pharmacopoeia of the XIV edition, GOST Р 57129-2016 and ICH Q1A: 2003 "Study of the stability of new pharmaceutical substances and drugs." During storage in natural conditions (temperature not higher than 25 ºС, in a dry place protected from light), in accordance with the current regulatory documentation and draft specification all three series of the drug were analyzed by indicators: description, authenticity, mass uniformity, dissolution, dosage uniformity, impurities, microbiological purity, quantitative determination. Results. As a result of stability analysis of the finished dosage form "Piron film-coated tablets, 50 mg", we can conclude that during the storage period in natural conditions (temperature not higher than 25 ºС, in a dry place protected from light) quality parameters met specification requirements. Conclusion. The stability of tablets of the new modern non-steroidal anti-inflammatory drug "Piron film-coated tablets, 50 mg" during storage was investigated and confirmed, when stored under natural conditions. The shelf life is at least two years.
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