IGF::OT::IGF PRODUCTION OF 650 BOTTLES OF TETRAHYDROURIDINE POWDER, HHSN261201200009I/HHSN26100009, DTP-16-003, DEVELOPMENT AND MANUFACTURE OF ORAL AND TOPICAL DOSAGE FORMS, PRBPERIOD OF PERFORMANCE

Irisys, Inc., San Diego CA

Investigators

Abstract

The Contractor will fill six hundred (600) containers with three grams (3g) of Tetrahydrouridine (THU) powder into each suitable size screw cap HDPE container, label (the label should be developed by consultation with COR) them, and conduct weight variation and chemical ID tests as QC release .The product will then be sent to the Clinical repository and Shelf life Contractor.