general chapters 美国药典USP41-NF36 下载积分: 1000 内容提示: General ChaptersGeneral InformationGeneral InformationThe chapters in this section are information, and aside from excerpts given herein from Federal Acts and regulations thatmay be applicable, they contain no standards, tests, assays, nor ...
These standards govern the quality, strength, purity, and potency of excipients, active pharmaceutical ingredients, pharmaceutical dosage forms, and many of the reagents, solutions, and indicators used to test these materials. Because of the extensive industry applicability of the United States ...
(1)在分析 USP 低分子肝素标准品 (USP Low Molecular Weight Heparin Molecular Weight Calibrant RS) 时,低分子肝素 (LMWH) 的最后一个洗脱峰和钠盐峰(或负峰)必须基线分离。 (2)当标准曲线用三次方程拟合时,相关系数必须大于 0.990。 (3)对USP 的 LMWH 标准样品进行分析,测得的重均分子量 (Mw) 与证书...
USP39 General chapters 目录Generalchapters 备注:蓝色字体章节为新增内容,红色字体章节为在USP38基本上修改内容。 〈1〉Injections,53 〈2〉Oraldrugproducts—productqualitytests,66 〈3〉Topicaland transdermaldrug products—product qualitytests,71 〈5〉Inhalationandnasaldrugproducts generalinformation...
undefinedGeneral Chapters: <191> IDENTIFICATION TESTS-GENERAL1 91 IDENTIFICATION TESTS—GENERAL Under this heading are placed tests that are frequently referred to in the Pharmacopeia for the identification of official articles. Before using any acid or base to modify the pH of the sample sol...
control of these impurities may be certified by a vendor, but purchasers also must corroborate the absence of impurities before using these materials in a manufactured article. The General Chapters Expert Committee of the USP Council of Experts formed an Ad Hoc ...
Requirements stated in these General Notices apply to all articles recognized in the USP and NF (the “compendia”) and to all general chapters unless specifically stated otherwise. Where the requirements of an individual monograph differ from the General Notices or a general chapter, the monograph...
..71USP32Introduction简介GENERALNOTICESANDREQUIREMENTS凡例和要求Changetoread:TheGeneralNoticesandRequirementssection(theGeneralNotices)presentsthebasicassumptions,definitions,anddefaultconditionsfortheinterpretationandapplicationoftheUnitedStatesPharmacopeia(USP)andtheNationalFormulary(NF).凡例和要求部分(凡例)给出对USP和...
凡例和要求部分(凡例)给出对 usp 和 nf 中假设、定义、默认条件的解释和应用。 requireme 4、nts stated in these general notices apply to all articles recognized in the usp and nf (the “compendia”) and to all general chapters unless specifically stated otherwise. where the requirements of an ...
4.20. General Chapters Each general chapter is assigned a number that appears in angle brackets adjacent to the chapter name (e.g., Chromatography 621). General chapters may contain the following: Descriptions of tests and procedures for application through individual monographs, Descriptions and ...