Almac’s analytical team deploys a wide range of capabilities to analyse your product. To suit your needs, we will develop methods in-house, or work with and adapt your existing methods.
We issue a Certificate of Analysis, specifying the batch number, identity, results of analyses, GMP status, and retest date. Stability studies are fully compliant with ICH standards.
- We are experienced in working with a wide range of analytes. Almac staff are experienced in method development, and able to quickly develop and validate a method to analyse customer material
- Existing analysis methods can be efficiently transferred to our facility, and verified for use with radiolabelled analytes
- HPLC systems with radioflow, UV and fluorescence detection
- Mass spectrometry
- Available for stable and radio-labelled products
- Radio-TLC using Cyclone Phosphor Imaging system
- Specific activity determination
- Mass spectrometric
- NMR (500 MHz)
- LC-MS, LC-MS-MS, and GC-MS for accurate determination of isotopic enrichment
We routinely conduct stability studies, ranging from short and informal, through to detailed studies over long periods, carried out to ICH standards.
- Validated –80 °C stability storage facility for radiochemicals
- Storage at 2-8°C, -20°C
- 25°C/60%RH, 30°C/65%RH, 40°C/75%RH stability chambers for stable-labelled materials