Stability Testing and Forced Degradation Studies for Pharmaceuticals

Element supports multiple regulatory pathways including IND applications for clinical investigation, ANDA submissions for generic drugs, and NDA filings for new molecular entities. The stability data generated follows ICH guidelines and addresses Chemistry, Manufacturing, and Controls (CMC) section requirements across these submission types, with testing protocols designed to meet specific reviewer expectations for each pathway.

Stability-indicating methods are specifically designed and validated to detect and quantify degradation products from the active pharmaceutical ingredient, even when multiple degradants form under stress conditions. Standard analytical methods might detect the API but miss critical impurities that develop during storage. A properly validated stability-indicating method demonstrates specificity for the drug substance in the presence of its degradation products, providing confidence that your analytical data accurately reflects product quality throughout shelf life rather than masking degradation behind unchanged API peaks.

Forced degradation involves exposing drug substances to stress conditions like heat, light, oxidation, reducing conditions, acid/base hydrolysis, and agitation to intentionally degrade the molecule and identify potential degradation pathways. This reveals how your product might degrade under real-world conditions, which pathways are most likely, and what degradants to monitor. Understanding degradation behavior early informs several critical decisions: which analytical methods can adequately separate and quantify degradants, what storage conditions protect product quality, which packaging materials prevent degradation, and what specifications appropriately control quality attributes throughout the proposed shelf life.

Integrated storage and testing within FDA-registered facilities eliminates coordination delays and sample transfer risks that occur when managing separate vendors. Samples remain under continuous ICH-compliant environmental control from storage pull through analysis, while scientists who understand both environmental parameters and analytical methods can address questions immediately when results require interpretation. This integration proves valuable when analytical results raise questions about storage conditions or degradation behavior, as answers come from the same team managing both aspects of your program.