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SM ISO690:2012 MOLDOVANU, Daniela, ŞTEFĂNEŢ, Tatiana. The importance of stability in ensuring the quality of medicines. In: Revista de Ştiinţe ale Sănătăţii din Moldova, 2022, nr. 3 An.1(29), p. 504. ISSN 2345-1467. |
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Revista de Ştiinţe ale Sănătăţii din Moldova | ||||||
Numărul 3 An.1(29) / 2022 / ISSN 2345-1467 | ||||||
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Pag. 504-504 | ||||||
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Background. The drug is a special product placed in the service of the patient, with the purpose of curing some diseases, protecting, or improving his health. The stability of a drug is, together with effectiveness, purity, and safety, an important factor in ensuring its quality. Objective of the study. To study and perform a literature review in order to determine the current requirements of drug stability criteria, as well as reliable methods of determining the stability of drugs. Material and Methods. Study, analysis, and synthesis of data selected from various literature sources that are related to the stability of drugs. Results. The pharmaceutical industry aims placing on the market-manufactured products guaranteed in terms of quality, action, and harmlessness. One of the four main factors that ensure the quality of a drug is presented by stability. The stability of drugs can be affected by various factors that require to be prevented. During the shelf life, the drug must present: physical, chemical, therapeutic, toxicological, microbiological stability. Conclusion. A medicinal product is considered stable as long as the proportion of the changes does not exceed the values provided in the specifications of the respective regulations (AND). The quality, therapeutic activity, and safety of medicines depend directly on their stability. |
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Cuvinte-cheie drug substance, stability, types of stability, substanță medicamentoasă, stabilitate, tipuri de stabilitate |
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