The stability testing of APIs is a crucial aspect of drug production, as it directly impacts the quality and efficacy of the medications. In the field of pharmaceutical production, stability testing is an indispensable procedure, as its outcomes directly affect the market competitiveness of drugs and user satisfaction. It’s necessary to thoroughly understand and delve into various aspects such as the theoretical foundation, practical exploration, regulatory guidance, and case studies in stability testing to ensure the quality and safety of pharmaceuticals.
Dr. Junqing Yang, who was invited due to his extensive experience in quality research of active pharmaceutical ingredients, appeared as a guest on the Cloud Lecture Hall live stream. Focusing on the core topic of API stability, she presented a comprehensive and multi-dimensional picture of knowledge related to API stability testing.
Q: Do the pre-influence factors need to be tested for a full 30 days? Should comparison experiments with packaging materials also be conducted?
Dr. Yang: The pre-influence factors don’t need to be tested for a full 30 days; they just need to achieve the intended investigation purpose. Because the pre-influence factors use samples from small trial batches, they do not meet the requirements for sample size specified in the application materials. Since no research data on pre-influence factors are provided during the application process, as long as we can achieve our investigative goals, it’s sufficient.
The same applies to comparison experiments with packaging materials; pre-influence factors are not required. Since this is just an preliminary investigation, there’s no need to set too many observation time points. The experiments with packaging materials can start from when the formal influencing factors are introduced.
Q: Can we consider it stable if only the color has changed?
Dr. Yang: Only based on this change in color, it cannot be determined whether it is stable or unstable, because the production batches at the current research stage are limited. We have relatively limited research on qualitative inspection items; so the change in color can serve as supporting evidence, but we cannot 100% determine the stability of the sample. It still requires support from other inspection items, such as infrared analysis, crystal structure, content, or relevant numerical trend changes.
Q: How to prevent problems during stability testing and what is usually done?
Dr. Yang: First of all, ensure that all testing activities comply with our SOP regulations, ensure that data is recorded promptly and truthfully, and ensure that the laboratory’s 5S self-inspection is thorough. Then, prepare for experiments well in advance, for example, by setting up internal inspection and circulation forms: Checklists (for preparation, operation, and review of experiments), using circulation checklists to specifically guide our workflow, ensuring that no steps related to the experiment are missed.
Q: How should a stability test chamber malfunction be handled?
Dr. Yang: It is important to note that the samples to be tested and the backup samples should be placed in different stability test chambers.
In case of stability chamber malfunction, the handling procedure is: switch to backup chamber > transfer to third-party storage with qualifications > lower storage conditions.
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