Stability Testing of Pharmaceutical Products
Sanjay Bajaj, Dinesh Singla, Neha Sakhuja, G Anderson, M Scott, H Bhutani, T Mariappan, S Singh, R Bott, W Oliveira, J Carstensen, C Rhodes, J Cha, T Gilmor, P Lane, J Ranweiler, A Gaur, T Mariappan, H Bhutani, S Singh, W Grimm, B Kommanaboyina, C Rhodes, A Lionberger, L Lee, L Lee, A Raw, X Yu, R Matthews, P Mischler, S Singh, M Bakshi, S Singh, M Bakshi, S Singh, H Bhutani, T Mariappan, H Kaur, M Bajaj, S Pakhale, S Singh, H Bhutani, T Mariappan, H Kaur, M Bajaj, S Pakhale, S Singh, S Singh, U Pharmacopoeial Convention
Abstract
Stability studies ensuring the maintenance of product quality, safety and efficacy throughout the shelf life are considered as pre-requisite for the acceptance and approval of any pharmaceutical product. These studies are required to be conducted in a planned way following the guidelines issued by ICH, WHO and or other agencies. Importance of various methods followed for stability testing of pharmaceutical products, guidelines issued for stability testing and other aspects related to stability of pharmaceutical products have been presented in a concise manner in the present review