The purpose of Stability Testing is to provide evidence on how the quality of a drug substances or drug products varies with time under the influence of a variety of environmental factors such as temperature, humidity and to establish a retest peroid for the drug substances or a shelf life for the drug products and recommended storage conditions.
Q1AR2
We are performing stability studies as per ICH guidelines (Q1A(R2)) for new drug substances and products.
Stability studies as per ICH guidelines
From study design, storage and shelf-life stability to monitoring, analytical testing and documentation, ITC Labs offers comprehensive stability testing services.
For the stability study of your pharmaceutical and biologic projects, you need world-class expertise and resources. With over 30 years of experience and currently more than 100 samples on storage, our laboratory has the skills and capacity to handle your pharmaceutical and biologic stability projects.
We provide a complete range of storage conditions in numerous climatic chambers and climatic cabinets. Various refrigerators and freezers are available for storage at lower temperatures also.
All storage chambers are fully controlled with 24/7 monitoring and alert systems (21 CFR part 11 compliant). For your reassurance, we operate back-up chambers for complete sample retrieval.
Stability study testing services
Under this service ITC Labs provides :
- Support in designing studies for real-time, stress tests and photostability studies
- Development and validation of stability indicating methods
- Examination of stability-relevant parameters
- Storage and management of stability samples
- Interim reports for every testing period
- Comprehensive final report
We offer the following climatic zones (according to ICH):
Long-term, intermediate and accelerated storage CONDITIONS &
- 25°C / 60% r.h.
- 30°C / 65% r.h.
- 40°C / 75% r.h
Long-term, intermediate and accelerated storage includes:
We also offers our chambers for Customer-specific conditions.
To find out more about our stability testing services, contact us today.