Author: Dr. Surya Prakash Gupta
Volume: 01
First Online: 31 August 2024
Pages: 87-122
DOI:

Stability testing protocols for elemental impurities are essential to ensure that drug products maintain their quality and safety over time. The selection of batches for stability testing is crucial, typically involving representative samples that reflect variations in production. Container orientation and storage conditions must be carefully considered, as these factors can influence the stability of elemental impurities in the product. Test parameters, such as temperature, humidity, and light exposure, are set according to regulatory guidelines, with specific sampling frequencies to monitor changes over time. The specification of stability testing protocols includes detailed instructions on how to perform tests, record results, and interpret data. Recording results meticulously is vital for identifying trends and potential issues early. The concept of stability commitment refers to the manufacturer’s obligation to continue stability testing post-approval, ensuring long-term product safety. Additionally, mechanistic studies provide important insights into how factors like temperature, pH, buffering species, ionic strength, and dielectric constant affect reaction rates and impurity formation. Practical considerations include the choice of appropriate analytical methods and ensuring that testing conditions mimic real-world storage scenarios. This comprehensive approach ensures that any potential risks associated with elemental impurities are identified and mitigated throughout the product’s shelf life.