Stability & Photostability Studies
State-of-the-art facilities
Temperature and humidity-controlled chambers
Monitored 24/7 with an alert system and consistent calibration
The state-of-the-art facilities at QNTM Labs are equipped with temperature and humidity-controlled chambers according to the ICH guidelines. The chambers are monitored 24/7 with an alert system and undergo stringent calibration regularly.
Stability Studies
QNTM Labs specializes in stability studies to assess products' shelf life and safety under various environmental conditions. Utilizing advanced analytical techniques and following strict regulatory guidelines, we provide crucial data on how products degrade over time and under different stresses, helping clients ensure product efficacy, safety, and compliance throughout their intended shelf life.
Long term Stability Studies: Monitoring products under recommended storage conditions to assess their shelf life and ensure they remain effective and safe until their expiration date.
Accelerated Stability Studies: Exposing products to elevated conditions such as increased temperature and humidity to predict long-term chemical stability and physical integrity over a shorter period.
Forced Degradation Studies: Intentionally breaking down products under severe conditions to identify potential degradation products and understand their pathways and mechanisms.
Specialized Environmental Conditioning Testing:
Cold storage testing at -80°Cand 5°C
Climate chamber testing at 25°C/60%RH, 30°C/65%RH, and 40°C/75%RH
Photostability Studies
Our photostability studies can provide important information related to product stability under exposure to light, which is crucial for maintaining the integrity and efficacy of light-sensitive materials. These studies are vital for pharmaceuticals, where light exposure can affect product quality and safety. We conduct these studies in compliance with ICH Q1B guidelines, providing essential data on how products respond to light and ensuring they meet rigorous regulatory standards and consumer expectations.
Controlled Light Exposure: Using calibrated light sources to replicate exposure to light, assessing the response of products to natural and artificial lighting conditions.
Rate of Degradation: Measuring the rate at which products degrade under light exposure to understand their stability and shelf life.
QNTM Labs' photostability studies offer valuable insights into products' photostability characteristics, aiding in formulation optimization, packaging decisions, and compliance with international quality standards. These studies ensure that products remain safe, effective, and stable throughout their intended lifecycle.