美国药典2021通则5.pdfVIP

Printed on: Mon Aug 09 2021, 06:35:13 PM Official Status: Currently Official on 09-Aug-2021 DocId: 1_GUID-63942EFA-FA01-4046-BF63-7C0706FD3924_7_en-US (EST) Printed by: Nguyen Nhan Official Date: Official as of 01-Dec-2020 Document Type: GENERAL CHAPTER @2021 USPC 1 á5ñ INHALATION AND NASAL DRUG PRODUCTS—GENERAL INFORMATION AND PRODUCT QUALITY TESTS 1. INTRODUCTION 2. GENERAL QUALITY TESTS FOR INHALATION DRUG PRODUCTS 3. GENERAL QUALITY TESTS FOR NASAL DRUG PRODUCTS 4. DESCRIPTION OF PRODUCT QUALITY TESTS Change to read: 1. INTRODUCTION Inhalation drug products deliver drugs into the lungs by oral inhalation and include inhalation aerosols, inhalation powders, inhalation sprays, inhalation solutions, inhalation suspensions, solutions for inhalation, and drugs for inhalation solutions dosage forms. Nasal drug products deliver drugs into the nasal cavity and include nasal sprays, nasal solutions, nasal aerosols, and nasal powder dosage forms. This chapter does not address nasal products in gel and ointment form. See Table 1 for established names and definitions of these dosage forms. Definitions of these drug product dosage forms, brief information about their manufacture, and a glossary of dosage form names can be found in Pharmaceutical Dosage Forms á1151ñ. [NOTE—All references to general information chapters are for informational purposes only, for use as a helpful resource. ▲See General Notices, 3.10 Applicability of Standards for further information on the applicability of USP standards pert