BRIEFING

 〈1664.1〉 Assessment of Leachables in Orally Inhaled and Nasal Drug Products. This proposal is based on the version of the chapter official as of August 1, 2015. It is proposed to revise this chapter to address specific, evolving considerations for leachables in orally inhaled and nasal drug products (OINDPs), including metered-dose inhalers (MDIs), nasal sprays, inhalation solutions, suspensions, sprays, and dry powder inhalers (DPIs). Updates include sections on elemental impurities, nitrosamines, and testing of additional leachable time points over the shelf life. The chapter considers organic and elemental leachables from two primary sources: process equipment used to produce the dosage form and container closure systems used to package the dosage form during its shelf life.

 Additionally, minor editorial changes have been made to update the chapter to current USP style.

 (GCDF: R. Kaja)

 Case ID—SUB-2306