BRIEFING

 〈1664.5〉 Oral Dosage Forms. The General Chapters—Dosage Forms Expert Committee is proposing to add this new chapter as a companion to Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems 〈1664〉. This new chapter addresses specific considerations for leachables in oral dosage forms (ODFs), including liquids (solutions, suspensions, emulsions, elixirs, and syrups), semisolids and pastes, and solids (tablets, capsules, powders, granules, and premixes). The chapter considers leachables from two sources: manufacturing systems used to produce the dosage form and container closure systems used to package the dosage form throughout its shelf life. Note that the following discussion is primarily devoted to organic leachables. For consideration of inorganic (i.e., elemental) leachables, see 〈1664〉.

 (GCDF: R. Kaja)

 Case ID—SUB-2257