Stability studies provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions.
Stability studies enable identification of any potential chemical or physical changes that could potentially impact product safety and quality.
Our stability studies (storage and testing) include:
Walk-in stability chambers with capacity of 50,000 Lts.
Stability studies (storage and testing) are performed as per ICH Q1A and photo stability testing as per ICH Q1B.
We offer conditions like 25℃/60%RH; 30℃/65%RH; 30℃/75%RH; 40℃/75%RH; 2-8 ℃ and/or customer requirements
Preparation of stability protocol, coordination, timely pull out and analysis of stability samples.
Real-Time Stability
Accelerated Stability
Photostability
Freeze-Thaw Study
We perform Stability Studies on:
Active Pharmaceutical Ingredients (APIs) / Drug Substance
