BRIEFING

 〈1664.2〉 Assessment of Leachables in Intramuscular, Intravenous, and Subcutaneous Parenteral Drug Products. It is proposed to add this new chapter as a companion to Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems 〈1664〉. On the basis of comments received, the proposal in PF 51(3) has been canceled and is being replaced with a new proposal. This new chapter addresses specific considerations for leachables in parenteral drug products (PDPs). It focuses on drug products (injections) administered by intramuscular, intravenous, and subcutaneous routes. Note that the following discussion is primarily devoted to organic leachables. For consideration of inorganic (i.e., elemental) leachables, see 〈1664〉 and Elemental Impurities—Limits 〈232〉.

 (GCDF: R. Kaja)

 Case ID—SUB-83