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FACTORS AFFECTING PRODUCT STABILITY

Each ingredient, whether therapeutically active or pharmaceutically necessary, can affect the stability of drug substances and dosage forms. The primary environmental factors that can reduce stability include exposure to adverse temperatures, light, humidity, oxygen, and carbon dioxide.
The major dosage form factors that influence drug stability include particle size (especially in emulsions and suspensions), pH, solvent [...]

What is Stability Study?

Stability is defined as the capacity of a drug substance or drug product to remain within the established specifications to maintain its identity, strength, quality and purity through out the retest or expiration dating period.
The objective of stability study is to determine the shelf life, namely the time period of storage at a specified condition [...]