Technical batch synthesis services include the production of your 14C-labeled API, so that the production steps can be tested and finalized. Then, using information from the technical batch synthesis, a detailed batch record will be developed for the GMP production of your 14C-labeled API. The batch record provides reassurance that your 14C-labeled compound will meet your deadlines and specifications, and all regulatory requirements. You can be confident in your 14C-labeled API because of Moravek’s technical batch synthesis services.
There are a variety of benefits to our technical batch synthesis services, including:
- Ensuring that the synthesis can be carried out to completion
- Providing material at the level of purity the cGMP specifications will require
- Resolving any issues that may arise during synthesis, purification, and/or analytical phases of the project.
- A Production Batch Record may be produced based on the documentation of the technical batch.
- Stability studies may be performed on the technical batch product to determine stability and the proper storage conditions of the labeled compound prior to producing the cGMP material.