Stability Study
MALPL offers comprehensive stability testing services according to ICH guideline Q1A (R2). Manisha Analytical Laboratory has installed 4 dedicated Newtronics stability walk-in chambers for real time and accurate conditions. A stand by walk-in chamber and generator backup is provided to ensure uninterrupted service even in case of power failure.
- 25°c± 2°c & 60%± 5% RH,
- 30°c ± 2°c & 65%± 5% RH,
- 30°c ± 2°c & 75%± 5% RH,
- 40°C ±2°c & 75%± 5% RH.
All walk-in chambers are completely automated and controlled through 21 CFR software. They are equipped with an emergency alert system, and are monitored 24x7.
Also, we have facility to expose samples for Photo stability conditions as recommended by ICH guideline Q1B.
To store reference standard and to maintain samples at cold condition, we have Cold chamber in place.
