内容提示:á1663ñ ASSESSMENT OF EXTRACTABLES ASSOCIATED WITHPHARMACEUTICAL PACKAGING/DELIVERY SYSTEMSPURPOSEThis general information chapter presents a framework for the design, justification, and execution of an extractablesassessment for pharmaceutical packaging and delivery systems. The chapter establishes ...
2020—2025年, USP共设立了专家委员会29个, 由来自41个国家和地区的996位专家组成(2021Annual Report)。其中药包材标准由通则-包装与流通(General Chapter-Packaging and Distribution, GCPD)专家委员会负责。 1.2 USP制修订流程 USP标准的制修订可由USP员工、监管方、企业或学术机构提出, 在提出的同时向USP递交支持...
Accessed from by copps4 on Tue Dec 27 20:14:28 EST 2016 1850 á1664ñ Assessment of Drug Product Leachables / General Information USP 39 á1664ñ ASSESSMENT OF DRUG PRODUCT LEACHABLES ASSOCIATED WITH PHARMACEUTICAL PACKAGING/DELIVERY SYSTEMS PURPOSE This general chapter presents a framework for...
USP42 1663 Printed on: Mon Apr 27 2020, 16:12:06 pmPrinted by: Huimin SunOf f i cial Status: Currently Of f i cial on 27-Apr-2020Of f i cial Date: Of f i cial as of 1-Aug-2018Document Type:GENERAL CHAPTERDocId:1_GUID-5B829ECA-165E-46C5-A244-3FF958BBC190_2_en-USPrinte...
General Chapter <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems General Chapter <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems <1664.1> Orally Inhaled and Nasal Drug Products General Chapter <661> Containers--...
Correspondence Number—C126512 Add the following: 1663 ASSESSMENT OF EXTRACTABLES ASSOCIATED WITH PHARMACEUTICAL PACKAGING/DELIVERY SYSTEMS PURPOSE ? This general information chapter presents a framework for the design, justification, and execution of an extractables assessment for pharmaceutical packaging and ...
CORRESPONDENCENUMBERC126512ADDTHEFOLLOWING1663ASSESSMENTOFEXTRACTABLESASSOCIATEDWITHPHARMACEUTICALPACKAGING/DELIVERYSYSTEMSPURPOSETHISGENERALINFORMATIONCHAPTERPRESENTSAFRAMEWORKFORTHEDESIGN,JUSTIFICATION,ANDEXECUTIONOFANEXTRACTABLESASSESSMENTFORPHARMACEUTICALPACKAGINGANDDELIVERYSYSTEMSTHECHAPTERESTABLISHESCRITICALDIMENSIONSOFANEXTRACTABLES...
Printed on: Mon Apr 27 2020, 16:13:56 pmPrinted by: Huimin SunOf f i cial Status: Currently Of f i cial on 27-Apr-2020Of f i cial Date: Of f i cial as of 1-Aug-2015Document Type:GENERAL CHAPTERDocId:1_GUID-D1C4D166-C281-45AA-893A-F324F3C79190_2_en-USPrinted from:...
If a monograph exists, it will reference 1 or indicated chapter parts. If a specific drug product monograph is missing (not in existence), the general chapters provide the quality tests that can be used by manufacturers until the dosage form monograph is developed by USP. The Pharmacopeial ...
成员由USP大会成员在每5年一次的会议上选举产生。专家委员会是监督USP科学和标准制定决策的机构。2020—2025年, USP共设立了专家委员会29个, 由来自41个国家和地区的996位专家组成(2021Annual Report)。其中药包材标准由通则-包装与流通(General Chapter-Pack...