ICH stability studies

RSSL offers comprehensive and cost-effective stability management, in accordance with GMP and ICH guidelines, providing a quality service to meet your specific storage and testing needs.

 

The long term stability of drug products (and other healthcare-related products) is key to their quality, efficacy, safety and commercialisation. As a result, it is vital to carry out stability studies conforming to ICH requirements that challenge your prototypes and products in a range of environments.  

 

To help pharmaceutical manufacturers meet these requirements, RSSL offers a comprehensive range of stability storage and testing services. Whether you require storage only or in combination with in-house analytical testing, we can tailor our stability service to meet your needs.  

 

Stability storage

 

Our pharmaceutical stability services include a range of monitored temperature, humidity, and light stability storage cabinets which comply with ICH Guidelines, covering requirements for climatic zones I to IV. In addition to being fully validated and 21CFR-compliant, our storage facilities are monitored 24 hours a day and have a dedicated out of hours response team on call in case of emergency. We are also fully licensed to store Schedule I to V controlled drugs.  

 

Stability storage conditions

 

  • -80°C and -20°C    
  • 5°C  
  • 25°C/60%RH    
  • 30°C/65%RH 
  • 30°C/75%RH and 40°C/75%RH 

 

We also provide bespoke conditions such as low temperature storage and non-standard temperature/humidity conditions upon request.  

Stability testing

 

We can offer a broad range of chemical, microbiological and physical analyses to assess the stability of your product and its packaging in accordance with GMP requirements. Alongside this, we also have experience in the development of bespoke pharmaceutical stability indicating methods, including photostability and other stress conditions. From protocol preparation to the issue of final reports, we offer comprehensive project management, plus advice and support. 

Contact Us

Need to get in touch? Either complete the enquiry form or call us:

Switchboard: +44 (0)118 918 4000

Customer Services: +44 (0)118 918 4076

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