GMP Purification and packaging of your [14C] API will be carried out in one of our highly engineered GMP suites. GMP Purification of [14C] API includes the following:
Benefits a technical batch synthesis provides are:
- Complete replacement of all wetted surfaces in the preparative HPLC system.
- New, never before used, HPLC preparative or semi-preparative column.
- 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 final product utilizing qualified instrumentation.
- Additional analyses available.
- Appropriate temperature storage and tracking – free of charge for the first year.
- Shipment to domestic and international destinations upon request
- Stability studies available on purified material.
- A minimum of weekly updates via email or teleconferences.