美国药典2021通则11.pdfVIP

Printed on: Mon Aug 09 2021, 06:36:43 PM Official Status: Currently Official on 09-Aug-2021 DocId: 1_GUID-041BE2C7-30A1-44FA-AC03-6F6997D2F251_3_en-US (EST) Printed by: Nguyen Nhan Official Date: Official as of 01-Nov-2020 Document Type: GENERAL CHAPTER @2021 USPC 1 á11ñ USP REFERENCE STANDARDS Change to read: ▲INTRODUCTION Reference Standards provided by the United States Pharmacopeial Convention (USP Reference Standards or USP RS) are highly characterized materials demonstrated to have the appropriate qualities to support their intended use. USP RS are not for use in humans or animals. USP RS are generally linked to relevant tests and assays in the United States Pharmacopeia ( USP) or National Formulary (NF) documentary standards. They have been approved and established as suitable for use in the context of these applications. When approved as suitable for use in USP or NF tests and assays, USP RS also assume official status and legal recognition in the United States and other jurisdictions that recognize the USP or NF (see General Notices, 2.30 Legal Recognition). Where USP or NF tests or assays call for the use of a USP RS, only those results obtained using the specified USP RS are conclusive (see General Notices, 5.80 USP Reference Standards). USP RS may also be used to support other measurements not necessarily prescribed in USP–NF. Assessment of the suitability for use in other applications is the responsibility of the user. ESTABLISHMENT APPROACHES AND VALUE ASSIGNMENT USP RS, when they are physical materials, are Reference Materials as defined in the International Vocab