Moravek, Inc.577 Mercury LaneBrea, CA 92821
A technical batch synthesis can be performed under good laboratory practices (GLP) prior to a full-scale synthesis under current good manufacturing practices (cGMP). Moravek’s expert chemists perform technical batch syntheses on 14C-labeled active pharmaceutical ingredients (APIs).
Technical batch synthesis services include the production of your 14C-labeled API under GLP conditions, 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 cGMP 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:
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