Stability testing evaluates how the quality of a drug substance or drug product changes over time under the influence of temperature, humidity, and light. The primary guideline is ICH Q1A(R2), finalized in 2003, which defines conditions for long-term, accelerated, and intermediate stability studies. Ovalab provides GMP-compliant stability testing for pharmaceutical manufacturers.
Key Facts About Stability Testing
- ICH Q1A(R2): “Stability Testing of New Drug Substances and Products” — defines storage conditions: long-term (25°C/60% RH), accelerated (40°C/75% RH), and intermediate (30°C/65% RH) for Climatic Zone II (EU).
- ICH Q1B: Photostability testing — evaluates the effect of light exposure on drug substances and products using a confirmed change in appearance or degradation.
- ICH Q1E: Evaluation of stability data — provides guidance on statistical methods for shelf-life estimation from stability study results.
- Study duration: Long-term studies: 12 months minimum at submission, 24–36 months for full shelf-life. Accelerated: 6 months. Testing intervals: 0, 3, 6, 9, 12, 18, 24, 36 months.
- Parameters tested: Assay, degradation products, dissolution, water content, microbiological quality, and appearance — per the relevant Ph. Eur. monograph.
Testing Methods at Ovalab
Ovalab performs stability-indicating analytical testing including assay, related substances/degradation products, dissolution, water content, and microbiological examination. Methods are validated per ICH Q2(R1) and executed under GMP certification (SÚKL 74726/2023) and ISO/IEC 17025:2017 accreditation (ČIA 537/2025). Results support marketing authorization applications and ongoing shelf-life confirmation.
Frequently Asked Questions
What is the purpose of stability testing?
Stability testing determines the shelf life (expiry date) and storage conditions of pharmaceutical products. It demonstrates that the drug remains within specifications throughout its intended storage period, as required for marketing authorization.
What are the ICH stability storage conditions for the EU?
For Climatic Zone II (EU): Long-term: 25°C ± 2°C / 60% RH ± 5% RH. Accelerated: 40°C ± 2°C / 75% RH ± 5% RH. Intermediate (if needed): 30°C ± 2°C / 65% RH ± 5% RH.
What is a stability-indicating method?
A stability-indicating analytical method can distinguish the active ingredient from its degradation products. It is validated to demonstrate specificity, ensuring accurate measurement of API content even in the presence of degradants.
How long does a stability study take?
Long-term studies require a minimum of 12 months data at the time of regulatory submission, with commitments to continue to the proposed shelf life (typically 24–36 months). Accelerated studies run for 6 months.
Can Ovalab perform photostability testing?
Yes. Ovalab conducts photostability studies per ICH Q1B guidelines, exposing samples to defined light conditions and testing for changes in appearance, assay, and degradation products.