Our cGMP purification and packaging services for [14C] API products are performed in state-of-the-art cGMP suites. The cGMP purification process includes the following:
- Complete replacement of all wetted surfaces in the preparative HPLC system
- Never-before-used HPLC preparative or semi-preparative columns
- Blank injection to verify the absence of contaminants in the system
- Purification of the [14C] API to provided specifications
- Aliquot preparation and packaging according to provided specifications
- HPLC, MS, and NMR Analyses of the purified material utilizing qualified instrumentation
- Availability of additional analyses
- Appropriate temperature storage and tracking – free of charge for the first year
- Shipment to domestic and international destinations upon request
- Stability studies available on the purified material
- A minimum of weekly updates via email or teleconference