Module 3 Presentations

07/05/2024

What is stability?

Type of Stability

Conditions Maintained Throughout the Shelf Life of the Drug Product Each active ingredient retains its chemical integrity and labeled potency, within the specified limits. The original physical properties, including appearance, palatability, uniformity, dissolution, and suspendability, are retained. Sterility or resistance to microbial growth is retained according to the specified requirements. Antimicrobial agents that are present retain effectiveness within the specified limits.

Chemical

Physical

Microbiological

Therapeutic Toxicological

The therapeutic effect remains unchanged. No significant increase in toxicity occurs.

Source: USP <1191>, STABILITY CONSIDERATIONS IN DISPENSING PRACTICE

The Organisation for Professionals in Regulatory Affairs

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What is stability testing?

Stability testing evaluates the effect of environmental factors on the quality of a drug substance or a formulated product which is utilized for prediction of its shelf life, determine proper storage conditions and suggest labeling instructions.

Source: Singh et al., 2000

The Organisation for Professionals in Regulatory Affairs

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