In Vitro Studies of the Stability of Ketoprofen Tablets based on the European Pharmacopoeia Guideline (ICHQ1A)

Mariana Ganea; Florina Miere; Laura Grațiela Vicaș; Corina Florentina Moisa

doi:10.51847/2ONwGtQgSK

Open Access | Published: 2021 - Issue 5

In Vitro Studies of the Stability of Ketoprofen Tablets based on the European Pharmacopoeia Guideline (ICHQ1A) Download PDF

Mariana Ganea , Florina Miere , Laura Grațiela Vicaș , Corina Florentina Moisa

Abstract

The stability of pharmaceutical forms over time and maintaining their quality in different storage and transport conditions is a very important aspect of the pharmaceutical industry. Thus, to determine the validity of the pharmaceutical product, the level of active substance in the pharmaceutical form is tested following the ICHQ1A norms from the European Pharmacopoeia.

This paper aims to perform stability tests on ketoprofen 100mg tablets. Long-term stability studies (36 months) were performed at a temperature of 25 ± 2^o C and relative humidity 60 ± 5% and short-term stability studies were performed under accelerated conditions (6 months) at 40 ± 2^oC and relative humidity 75 ± 5%. The amount of ketoprofen released from the 100mg ketoprofen tablets was determined by high-performance liquid chromatography. According to these studies, it was shown that the validity of ketoprofen 100mg tablets can be 3 years, the amount of ketoprofen contained in tablets being over 95% after 36 months.

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Vancouver

Ganea M, Miere F, Vicaș LG, Moisa CF. In Vitro Studies of the Stability of Ketoprofen Tablets based on the European Pharmacopoeia Guideline (ICHQ1A). Pharmacophore. 2021;12(5):1-6. https://doi.org/10.51847/2ONwGtQgSK

APA

Ganea, M., Miere, F., Vicaș, L. G., & Moisa, C. F. (2021). In Vitro Studies of the Stability of Ketoprofen Tablets based on the European Pharmacopoeia Guideline (ICHQ1A). Pharmacophore, 12(5), 1-6. https://doi.org/10.51847/2ONwGtQgSK

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