MANUFACTURING PROCESS DEVELOPMENT OF 4-HB

Leidos Biomedical Research, Inc., Frederick MD

Investigators

Abstract

The overall objective of this project is for the contractor to support the chemistry, manufacturing, and controls (CMC) development of 4-HB. The objectives of this study are: 1. The contractor shall develop a manufacturing process for 4-hydroxybenzoic acid (4-HB) based on the suggested scheme (1,2, and 3) and develop a cost and operation-efficient process for generating GMP batch 4-HB. 2. The contractor shall perform analytical development to release 4-HB and detect all related impurities. 3. The contractor shall perform a long-term stability study on 4-HB.