Technical Batch Synthesis

A technical batch synthesis can be performed under GLP conditions prior to a full-scale cGMP synthesis. Moravek’s expert chemists perform technical batch synthesis on non-labeled and labeled compounds. There are a variety of benefits to technical batch syntheses, including:

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  • Ensuring that the synthesis can be carried out to completion, providing material at the level of purity the cGMP specifications will require
  • Resolving any problematic 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.