We have developed a written program for stability determination which includes elements such as a complete description of the drug studied. Complete testing parameters, methods describing all tests as per the specification of each product formulation.
Accelerated and real time stability studies are performed within our company. We have sufficient accelerated stability chambers where accelerated stability studies are conducted at 30±2℃/75±5%RH and 40±2℃/75±5% RH.
Real time stability studies are conducted in real time stability chamber where storage condition is set according to the need of targeted markets. The retention sample room is well maintained. Temperature and humidity is routinely checked and recorded.