Background: Pharmaceutical product’s stability testing is a
complex series of processes that requires a lot of money, effort, and
scientific knowledge to incorporate quality, efficacy, and safety into a
medicine formulation.
Aim & Objective: The goal of the current study is to assess how
accelerated storage conditions will affect prepared capsules. The objective of
the study is to assess the effects of accelerated storage conditions on formulated
Trasina® capsule.
Materials & Methods: To test for stability under accelerated conditions
(Temperature: 40°C ± 2, Relative Humidity: 75% ± 5) in accordance with ICH
recommendations Q1A (R2). For six months under expedited circumstances, the
study sample was monitored for changes in various parameters such the physical,
chemical, and microbiological load.
Results: No physical changes in taste, colour, or odour
were noticed after up to six months of accelerated storage. Disintegration time
of the capsule throughout the period within the prescribe standard. Additional
variables like pH, total ash, acid soluble ash, and loss on drying were all
within the established standard range. Bacterial count overall is significantly
lower than expected.
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