Stability Testing

Stability studies play a crucial role in the estimation of the shelf life of new drugs. Typically, drug products, drug substances, and placebo samples are stored under controlled environmental conditions including humidity, temperature, or exposure to light, followed by analysis at different time points. The data accumulated over time is used to determine the effects of different environmental conditions on product quality and to estimate shelf life.

Stability studies are performed during all phases of drug development, including post-licensure studies, which are used to further monitor drug stability.

Our GMP QC Services provide potency testing of stability samples to support both GMP and non-GMP stability studies. Additionally, we perform exploratory stability testing.

Our Expert QC Services team is standing by to discuss the design of your stability study and the interpretation of guidelines such as:

  • Q1A(R2): Stability Testing of New Drug Substances and Products
  • Q5C: Quality of Biotechnological Products – Stability Testing of Biotechnological/Biological Products.

Reach out to learn more about our GMP QC Testing Services using the form below.

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