STABILITY TESTING OFNEW DRUG SUBSTANCES AND PRODUCTS Q1A(R2)-
STABILITY TESTING OFNEW DRUG SUBSTANCES AND PRODUCTS Q1A(R2)
2024-02-21
Stability Testing ofNew Drug Substances and Products
2.1.1. General
Information on the stability of the drug substance is an integral part of thesystematic approach to stability evaluation.
2.1.2. Stress Testing
Stress testing of the drug substance can help identify the likely degradation products.which can in turn help establish the degradation pathways and the intrinsic stabilityof the molecule and validate the stability indicating power of the analyticalprocedures used. The nature of the stress testing will depend on the individual drugsubstance and the type of drug product involved.
Stress testing is likely to be carried out on a single batch of the drug substance. Itshould include the effect of temperatures (in 10°C increments (e.g., 50°C, 60°C, etc.)above that for accelerated testing), humidity(e.g., 75% RH or greater) whereappropriate, oxidation, and photolysis on the drug substance. The testing should alsoevaluate the susceptibility of the drug substance to hydrolysis across a wide range ofpH values when in solution or suspension. Photostability testing should be anintegral part of stress testing. The standard conditions for photostability testing aredescribed in ICH Q1B.
Examining degradation products under stress conditions is useful in establishingdegradation pathways and developing and validating suitable analytical procedures.However, it may not be necessary to examine specifically for certain degradationproducts if it has been demonstrated that they are not formed under accelerated orlong term storage conditions.
Results from these studies will form an integral part of the information provided toregulatory authorities.
2.1.3. Selection ofBatches
Data from formal stability studies should be provided on at least three primarybatches of the drug substance. The batches should be manufactured to a minimum ofpilot scale by the same synthetic route as, and using a method of manufacture andprocedure that simulates the final process to be used for, pro