The Importance of Stability Testing for Pharmaceuticals – Beyond the Basics
Stability testing is essential throughout drug development to understand how the Active Pharmaceutical Ingredient (API) and final product degrade over time.
Why stability testing matters ?
In the early phases, limited information is available about the API and its formulation. Therefore, stability studies are essential to understand how the compound degrades over time and under various conditions such as light, heat, and humidity. This knowledge helps determine appropriate storage conditions to ensure the drug maintains its safety, efficacy, quality and purity.
As the formulation step progresses, it’s also necessary to investigate how the API interacts with excipients or any other drug delivery system, and whether these interactions might accelerate degradation. Once the final product is packaged, further stability testing is required to confirm that the packaging protects the product effectively and that the drug remains stable throughout its shelf life.
The need to consider the drug substance life cycle
During early clinical development, every new batch of API or drug product should undergo stability testing. Similarly, any new packaging format must be supported by stability data. Conducting stability studies involves several considerations: the analytical methods used must be robust and validated, especially under Good Manufacturing Practice (GMP) conditions. These methods must be capable of detecting degradation accurately.
As the drug moves closer to commercialization, multiple product combinations may need to be tested to check the best packaging format.
Stability testing duration: months or years?
Stability studies are typically conducted over three to five years. Early in development, products are subjected to harsher conditions to accelerate degradation and reveal potential issues. These stress tests help predict shelf life and ensure the analytical methods are specific and sensitive enough. These forced degradation studies are used to understand the intrinsic stability of drug substances.
Quality Requirements – ICH guidelines
They became a formal regulatory requirement with the International Conference on Harmonization (ICH) guideline Q1A in 1993. Stress testing involves exposing drugs to harsher conditions than accelerated stability tests to identify degradation products and mechanisms.
These studies are required not only for new drugs but also for generics, and are included in various ICH guidelines [1] (Q1A(R2), Q1B, Q2(R1), Q3A, Q3B, Q5C) and national regulations worldwide. They are also referenced in some pharmacopoeias, reflecting their global importance in drug development and quality assurance.
Common tests include purity analysis (often via HPLC), moisture content, solid state analysis, and sometimes microbiological testing. For finished products, dissolution testing is also performed to simulate how the drug behaves in the body.
In addition to fixed-condition studies, real-world scenarios are considered through transport and in-use stability testing. These simulate challenges like shipping delays or temperature fluctuations. For instance, a product might undergo temperature cycling between -20°C and 40°C with high humidity before being placed on a long-term stability study. This approach helps ensure product integrity during distribution.
Stability testing chambers
Comprehensive stability data should be carried out in appropriate stability testing chambers with controlled humidity, temperature and controlled light exposure (photostability). These rooms include dedicated equipment for the testing of products and simulate the effects that a range of temperature and humidity conditions have on a product or material. Samples are checked periodically for quality analysis.
SEQENS’ expertise on Stability Testing
At SEQENS, more than 2000m3 of secured ICH storage is implemented at Seqens’ Lab in Porcheville, Fr and in Devens, USA.
Long-term study
We have the expertise and capacities for conducting a large range of stability studies of products, including long-term conditions, accelerated storage, refrigerated and freezer storage conditions.
Through stability studies, we can also aid in determining the most suitable excipients, packaging materials.
We not only store your product at your specified temperature ranges and humidity levels but we can
assist with proper pull protocols for your batches and can set up automated schedules to provide your drug substances and products for testing at the proper intervals.
Analytical excellence through the drug substance life cycle
At SEQENS, we have the expertise and cutting-edge assets for conducting the full range of ICH analysis from early-stage product development to commercial scale.
Our facility offers the following ICH storage conditions:
• Long-Term and Intermediate conditions of 25°C/40%RH, 25°C/60%RH, 30°C/65%RH, 30°C/ 75%RH, 30°C/35%RH,
• Accelerated storage of 40°C/not more than (NMT) 25%RH, 40°C/75%RH
• Refrigerated and Freezer storage conditions of 2°C – 8°C (5°C), -20°C, and -80°C
We provide additional capabilities:
• Suntest equipment for photostability
• Cycling cabinet
• Specific customized conditions
The stability storage is in a fully secured building dedicated to stability storage providing:
• Access control to buildings and walking chambers,
• Camera on site,
• Site security (24/7) with 2 officers.
In addition, we provide the highest level of storage continuity with:
• Temperature Monitoring System with Centralized Alarm Management System
• Back-up chamber qualified at every conditions
• Site power generators (x2) qualified
As an integrated Leader, we provide the full services and capabilities to manufacture your Active Ingredients.
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