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Qualification of Excipients for Use in Pharmaceuticals
ipecamericas.org2.3.1 Safety, Toxicological, and Precedence of Use Issues 4 2.3.2 New (Novel) Excipients 5 2.3.3 Compendial Requirements 6 General Comments 6 United States Pharmacopeia 7 European Pharmacopeia 8 Japanese Pharmacopeia 8 New and Novel Excipients not listed in a Pharmacopoeia 8 Other regulatory requirements 10