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Stability of a pharmaceutical product refers to the capability of a drug substance to maintain its physical, chemical, microbiological, toxicological properties in a specific container/closure system. This means that within the specified limits, a drug product retains the same properties and characteristics possessed at the time of its packaging throughout its period of storage and use. Therefore, the stability test can evaluate the effects of environmental factors such as temperature, humidity, and illumination on the quality of the drug or formula, and can test the shelf life of the product to determine the appropriate storage conditions and recommend a label for the drug.
Alfa Chemistry is your one-stop Stability Testing Partner, and our stability testing lab is well equipped with advanced instruments. We have decades of experience in ICH stability testing and are able to provide FDA-specified stability testing and GMP stability testing in compliance with regulatory requirements for drugs to be marketed. When you face a stability testing challenge, our experienced team of professionals can offer you a comprehensive solution rapidly, to help you minimize your risk and save your cost and time. Our capabilities include but not limited to:
The stability of the pharmaceuticals in storage is vital to maintain its efficacy. Recommendations for storage conditions are generally provided by ICH and WHO. The table below lists the storage conditions for stability testing:
Intended Storage Condition
Stability Test Method
ICH Test Temperature, Humidity and Period
WHO Test Temperature, Humidity and Period
25±2°C, 60±5% RH, 12 months
25±2°C, 60±5% RH or 30±2°C, 65±5% RH or 30±2°C, 75±5% RH,12 months
Some groups in the drug structure, such as phenolic hydroxyl groups, double bonds, etc., are sensitive to light. Light may cause changes in the color of the drug and increase impurities. Therefore, the photostability of the new drug substance and products should be tested and evaluated to prove that proper light does not cause changes in the physical, chemical, and microbiological stability of the drug. ICH Q1B has developed guidelines for the photostability of new molecular entities and associated drug products, and systematic photostability studies have been conducted on the drug products, including the exposed drug product outside of the immediate pack, the drug product in the immediate pack and marketing pack.
The Container Closure Integrity Test (CCIT) assesses whether a closed container system has a sterile barrier protection against potential contaminants. Contaminants that may pass through the container to close the barrier include microorganisms, reactive gases and other substances. Therefore, the integrity of container closure has always been a topic of concern for pharmaceutical industry workers. At present, there are many guiding documents and regulations for managing closed integrity systems, and the technical threshold for drug quality control is increasing. USP <1207> proposes a variety of deterministic detection methods and classifies traditional methods such as microbial challenge methods as conceptual testing methods.
Alfa Chemistry's advantages:
Short Detection Cycle
Experienced Team of Experts
Familiar with Various Standards
Bajaj, S. (2012) 'Stability testing of pharmaceutical products.'; Journal of Applied Pharmaceutical Science, 2(3), 129-138.
ICH Q1A(R2). (2003) Stability testing guidelines: Stability testing of new drug substances and products.
ICH Q1B. (1996) Guidance for Industry: Photostability testing of new drug substances and products.
WHO. (2004) Stability studies in a global environment. Geneva meeting working document QAS/05.146 with comments.