At JC Analytical we currently operate and manage stability studies to various levels for our clients depending on their individual requirements. Our services range from complete performance and management of studies to simple storage of samples and anything in between. All studies are performed in compliance with cGMP and ICH Guidance Stability testing of new drug Substances and products Q1A(R2). We routinely maintain stability storage chambers at 25°C/60%RH, 30°C/65%RH and 40°C/75%RH and have other chambers, which can be set to other conditions for specific studies as required.
We regularly store Active Pharmaceutical Ingredients (APIs), bulk drugs, intermediates, excipients, finished products, cosmetics and products for veterinary use in validated and monitored temperature and humidity controlled conditions that have back up emergency systems in place.
Study services we offer:
Full Study – including preparation of study protocols, storage of samples, management of sampling timepoints, testing of samples at each timepoint (Chemical and Microbiological), regular reporting and trending of results and preparation of the final study report.
Storage, sampling and testing – including storage of samples to your own defined protocol, management of sampling timepoints, testing of samples at each timepoint (Chemical and Microbiological), and regular reporting. The option for reporting on trending of results is also available.
Storage and sampling – including storage of samples to your own defined protocol, management of sampling timepoints and despatch of samples at defined intervals to an external testing site.
Storage only – including storage of samples as required for call off for testing as and when required.