The Applied Technical Services Family of Companies’ (ATS FoC’s) pharmaceutical testing laboratory offers ICH stability testing to assess how drug substances and products retain quality, safety, and performance over time. This testing evaluates changes under controlled conditions, such as temperature, humidity, and light. The resulting data help manufacturers determine storage conditions, retest periods, and shelf life. ICH Q1A outlines core stability data requirements for new drug substances and products, while related guidelines address photostability and alternative study designs. We support flexible study designs, controlled storage, defined time points, and project-specific testing.
Which Pharmaceutical Products Can Undergo ICH Stability Testing?
ICH stability testing applies to a wide range of pharmaceutical materials during development, registration, and throughout the product lifecycle. Our laboratory supports stability programs for:
- Drug substances and active pharmaceutical ingredients
- Finished drug products
- New molecular entities and associated drug products
- Different dosage forms and formulations
- Products requiring specialized storage or packaging conditions
Stability programs assess changes in physical, chemical, biological, or microbiological properties, as appropriate for each material and study design. Related ICH guidance also covers considerations for new dosage forms and biotechnological products.
About Our Stability Testing Services
We offer flexible ICH stability testing programs tailored to your product, protocol, and regulatory needs. Our capabilities include controlled storage, customized study configurations, and continuous environmental monitoring. We support study designs based on specific project requirements. Our services include:
- Long-term and accelerated stability studies
- Intermediate stability studies
- Photostability testing
- Stress and forced degradation studies
- Bracketing and matrixing study designs
- Specified stability time points and sampling configurations
- Controlled temperature and humidity storage
- Stability testing for drug substances and drug products
We tailor study conditions, sample quantities, testing schedules, and protocols to meet your project requirements. This flexibility enables manufacturers to develop stability programs aligned with product characteristics, development goals, and ICH guidelines.
How Does ICH Stability Testing Support Pharmaceutical Development and Regulatory Submissions?
ICH stability testing provides documented evidence of how pharmaceutical materials change over time under specific environmental conditions. Manufacturers use this data to set retest periods, shelf life, and storage recommendations. Stability data also help identify degradation pathways, assess formulation and packaging, and confirm products meet acceptance criteria throughout their lifecycle. Since ICH guidelines offer harmonized technical standards for development and registration, robust stability studies support regulatory submissions.
Contact Us
To discuss your ICH stability testing needs, please submit our online request form or call +1 (888) 287-5227.
