Performing ICH stability studies in-house is time intensive and costly. At Recipharm, we make your stability studies our business. Through our cGMP stability service, we take on the time and resource burden of stability testing, leaving you to focus on what you do best.
Our customers need routine reliable testing. Whether you are a big pharma company that prefers to use external resources, or a small R&D team without the laboratory facilities or technical expertise, we can take ICH stability studies off your hands.
Everything from sample receipt, shipment and reporting is performed from a single GMP approved facility – our centre of excellence for stability study services. Since 1987, the facility has been operating to the highest quality standards, while also delivering a cost effective service.
Our team of more than 75 experienced scientists, provide stability study services including:
- Logistics including sample transportation and import requirements
- Long-term drug ICH stability studies
- Accelerated ICH stability studies
- Shelf-life assessment
- In-use studies
- Short-term temperature excursion studies
- Restricted access control, stability storage rooms set as per ICH stability conditions
- Forced degradation and photostability studies for developing stability indicating methods and to understand the nature of molecules
- Stability chambers are available at conditions to cater for all climatic zones as per ICH guidelines (ICH Q5C and ICH Q1B)
- Freeze-thaw & temperature cycling
- Support for schedules II, IIIN, and IV controlled substances
- State-of-the-art analytical capabilities including microbiology testing
- Impurity identification and qualification
- Execution of protocol, data analysis and final report
Our customers use our stability studies services for a number of reasons, including:
We provide flexible solutions to suit all types of customers, including fee per sample analysis, fee per hour, a FTE programme and dedicated analytical testing laboratories.
Thanks to our quality culture and strong track record spanning over 30 years, you can trust us with your stability studies. Our facility is EU QP approved and has been FDA inspected in 2012, 2015 and 2017 with no critical or major issues.
Our location in India provides cost advantages without compromising quality standards.