They contain no mandatory requirements applicable to any official article unless specifically referenced in General Notices, a monograph, or a general chapter numbered below 1000. General chapters numbered above 2000 apply only to articles that are intended for ...
(e.g., temperature, time, agitation method). Control of these factors during solubility measurements is key to obtaining accurate, reliable values for the equilibrium solubility of a material. This chapter will begin with a discussion of the concepts and equations that are relevant to solubility ...
《美国药典-国家处方集》(USP-NF)中的通用检测方法收录在通则(General Chapter)中，所有的通则都是强制...
When a general chapter is referenced in a monograph, acceptance criteria may be presented after a colon. 当在专论中引用通则时,接受标准可以在冒号后提出。 Some chapters may serve as introductory overviews of a test or of analytical techniques. They may reference other general chapters that contain...
《美国药典-国家处方集》(USP-NF)中的通用检测方法收录在通则(General Chapter)中,所有的通则都是强制执行的吗? 回答: 在USP37-NF32 第二增补本的凡例(General Notice)中“2.OFFICIAL STATUS AND LEGAL RECOGNITION”项下有如下规定: “2.10. Official Text Official tex...
当限值与下面提供的数值相符合，残留溶剂的测试方法一般不会在专论中特别，因为不同制造商所使用的溶剂不同。The objective of this general chapter is to provide acceptable amounts of residual solvents in pharmaceuticals for the safety of the patient. The chapter recommends the use of less toxic ...
5、s apply and supersede the requirements of the general notices or the general chapter, whether or not the monograph explicitly states the difference. 除另有规定外,凡例中的要求应用于所有 usp 和 nf 公认的(即药典的)药品,也适用于所有 附录。如果专论的要求与凡例或附录要求不同,无论专论是否说明...
Chapter <1092> addresses the development andvalidation of dissolution procedures, with a focus on solid oral dosage of the concepts presented, however, may be applicable to other dosageforms and routes of administration. General recommendations are given with theunderstanding that modifications of the ...
Appropriate selection of the solvent for the synthesis of a drug substance or an excipient may enhance the yield, or determine characteristics such as crystal form, purity, and solubility. Therefore, the solvent may sometimes be a critical element in the synthetic process. This general chapter ...
Appro-priate selection of the solvent for the synthesis of a drug substance oran excipient may enhance the yield, or determine characteristics suchas crystal form, purity, and solubility. Therefore, the solvent maysometimes be a critical element in the synthetic process. ThisGeneral Chapter does ...