Skip to main content

Long-Term Stability

Meaning

Long-Term Stability is a critical quality assurance metric in pharmaceutical science, describing the ability of a drug product, particularly compounded or innovative hormonal preparations, to maintain its physical, chemical, microbiological, and biopharmaceutical integrity over an extended period. Ensuring this stability is essential to guarantee that the product retains its specified potency and therapeutic efficacy up to the expiration date under defined storage conditions. It is a non-negotiable requirement for patient safety and predictable clinical outcomes.