Wednesday, May 13, 2015

What is the purpose of stress testing in stability studies?

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 stability of the molecule and validate the stability indicating power of the analytical procedures used. The nature of the stress testing will depend on the individual drug substance and the type of drug product involved.

What countries comes under climatic zone ivb?

Brazil, Cuba, China, Brunei, Cambodia, Indonesia, Malaysia, Myanmar, Philippines, Singapore, Thailand

According to WHO guidelines what is the storage condition of climatic zone iva and zone ivb?

Zone IV a: 30°C and 65% RH (hot and humid countries)
Zone IV b: 30°C and 75% RH (hot and very humid countries)