<905>UNIFORMITYOFDOSAGEUNITS(HarmonizedChapter,OfficialApril1,2006)……2780制剂单 位的含量均匀度(协调的章节2006.4.1) <911>VISCOSITY……2785粘度 <921>WATERDETERMINATION……2785水测定法 <941>X-RAYDIFFRACTION……2788X光衍射 GeneralInformation通用信息 ...
USP39 General Chapter <1225> Validation of Compendial Procedures
sothereisnoneedformethodrevalidationaftermodifications.ManyusersinthepharmaceuticalfieldexaminethepossibilityofmethodtransferbyusingtheallowedadjustmentsintheUSP/EPmethodasawaytospeedupnewdrugdevelopmentandreducesolventandwastedisposalcost.USPGeneralChapter<621>EPGeneralChapter<2.2.46>ColumnLength±70%±70%ColumnI.D....
14页 顶/踩数: 0/0 收藏人数: 5 评论次数: 0 文档热度: 文档分类: 待分类 系统标签: index加亮chapter认领testsgeneral <861>Sutures---Diameter<871>Sutures---NeedleAttachment<691>Cotton<1151>PharmaceuticalDosageForms<1196>PharmacopeialHarmonization<1225>ValidationofCompendialProcedures[Note:ThisTableandthech...
USP General Chapter Revisions: Industry Experts Offer Best Practices To Avoid Destructive, Unreliable Integrity Testing
technology and includes limits that are based on toxicity and exposure levels for the selected metals. The new General Chapter also introduces a performance-based approach for the selection of the appropriate technology. This chapter is proposed to replace <231> and may impact other General Chapters...
In accordance with the Rules and Procedures of the 2005–2010 Council of Experts, section 9.08(c), USP is postponing, for a second time, General Chapter <2040> Disintegration and Dissolution of Dietary Supplements, Dissolution Soft Gelatin Capsules official date to August 1, 2011. Affected Text...
<467>溶剂残留 简介：INTRODUCTION This general chapter applies to existing drug substances, excipients, and products. All substances and products are subject to relevant control of solvents likely to be present in a substance or product.本章节适用于现有的原料药，辅料和制剂。应对原料药或制剂产品中可能...
General chapter 41 provides requirements for balances used for materials that must be accurately weighed. The balance user should check the balance environment (vibration, air currents, and cleanliness) and status of calibration before use. 根据数量和要求的性能选用适当的天平。通论 41 中提供了用于必须...