Pharmaceutical Stability Study Guideline

Guidelines for conducting stability studies for new products are as follows: 1. Formal stability studies should include accelerated and long-term stability testing in at least two primary production batches for stable drug products and at least three primary production batches in the case of sensitive ...

Long-term stability studies

Long-term, or real-time, stability testing programs subject products to recommended storage conditions and typically use a longer observation period for degradation to establish the product’s shelf-life. This testing method differs from accelerated shelf-life testing, which instead exposes products ...

Stability study

Stability study: It is the study to determine the self-life of a product how much time the product remain stable in the market and confirm with product specification meet the pharmacopoeia limit. Stability testing is integral to developing new pharmaceutical merchandise and active pharmaceutical ingredients, ...
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