STUDY OF THE STABILITY AND DETERMINATION OF THE SHELF LIFE OF A COMBINED INFUSION SOLUTION BASED ON L-ARGININE HYDROCHLORIDE
Keywords:
Stability, shelf life, expiration date, packaging, storage conditions, infusion solutionAbstract
In the field of pharmacy, it is essential for any pharmaceutical product to undergo comprehensive stability testing. This is a critical step before a product can be approved and made available to the public. The purpose of these tests is to ensure that the product's quality, safety, and efficacy remain consistent throughout its entire shelf life. This article details a stability study and the subsequent shelf-life determination for an investigational drug, a hepatoprotective infusion solution known as "Gepaton."
References
I.V. Sakaeva, N.D. Bunyatyan, E.L. Kovaleva, E.I. Sakanyan, L.I. Mit’kina, I.A. Prokopov, E.S. Shelekhina, Yu.V. Mit’kina, Basic approaches drug stability studies: domestic and international experience. Quarterly peer-reviewed scientific and practical journal, No. 3, 2013.
State Pharmacopoeia of the Republic of Uzbekistan. Vol. 1. — Tashkent: Ministry of Health of the Republic of Uzbekistan, 2020.
ICH Q1A(R2). Stability Testing of New Drug Substances and Products. International Council for Harmonisation, 2003.
A. I. Belanova*, E. L. Kovaleva, L. I. Mit’kina, Comparison of Approaches to Stability Testing of Medicines in the Russian Federation and the Eurasian Economic Union. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 2021. V. 11, No. 1
Da-Young Lee, Eun-Hee Kim, Therapeutic Effects of Amino Acids in Liver Diseases: Current Studies and Future Perspectives// JOURNAL OF CANCER PREVENTION Vol. 24, No. 2, June 2019.
Aglokhodjaeva Sh.M., Tashpulatova A.D. Validation of an HPLC method for the quantitative determination of active ingredients of a combined infusion solution. Pharmacy, 2025; (2): 23-29 https://doi.org/10.29296/25419218-2025-02-03
