<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 ...
in 0.1-mm cells unless a different cell path length is specified in the individual monograph. The reference 〈197A〉 signifies that the substance under examination is intimately in contact with an internal reflection element for attenuated total reflectance (ATR) analysis. The reference 〈197...
197SPECTROPHOTOMETRICIDENTIFICATIONTESTSSpectrophotometrictestscontributemeaningfullytowardtheidentificationofmanycompendialchemicalsubstances.ThetestproceduresthatfollowareapplicabletosubstancesthatabsorbIRand/orUVradiation(seeSpectrophotometryandLight-Scattering851).TheIRabsorptionspectrumofasubstance,comparedwiththatobtainedconcomitantl...
1、USP29-通用章节指导目录(附录)第2页 共7页8通用章节指导Guide to General Chapters目录中此颜色并且带有“ * ”的为新增内容General Requirements for Test and Assays 检查与含量分析的一般要求V 1 INJECTIONS 2455 注射剂V 11 USP REFERENCE STANDARDS 2458 USP 对照品Apparatus for Test and Assays 用于检查...
cial Date: O?cial as of 1-Sep-2021Document Type: GENERAL CHAPTERDocId: 1_GUID-37232E7C-5275-4B7B-9007-9587E166E4C1_5_en-US© 2021 USPC〈197〉 SPECTROSCOPIC IDENTIFICATION TESTSChange to read:INTRODUCTION AND SCOPEThis chapter provides several tests and procedures that are used to con?
sothereisnoneedformethodrevalidationaftermodifications.ManyusersinthepharmaceuticalfieldexaminethepossibilityofmethodtransferbyusingtheallowedadjustmentsintheUSP/EPmethodasawaytospeedupnewdrugdevelopmentandreducesolventandwastedisposalcost.USPGeneralChapter<621>EPGeneralChapter<2.2.46>ColumnLength±70%±70%ColumnI.D....
a new USP General Chapter for the control of inorganic impurities in drug and dietary supplement articles intended for use in humans. For the purposes of this article, inorganic impurity, metal, and element all refer to those elements listed in Table 1. The proposed new General Chapter ...
General Chapter <797>: pharmaceutical compounding--sterile preparations. In: United States Pharmacopeia 38--national formulary 33. Rockville (MD): United States Pharmacopeial Convention, Inc.; 2015:567-611... L Jenkins - 《Therapeutic Innovation & Regulatory Science》 被引量: 5发表: 2016年 A Pri...
The USP Parenteral Products-Industrial Expert Committee (PPI EC) has worked during the past three revision cycles to revise USP General Chapter Elastomeric Closures for Injection (381). This Stimuli article summarizes these efforts and in the Appendix provides an overview of the current draft revision...
DocumentType:GENERALCHAPTER DOI:/10.31003/USPNF_M16255_02_01 印刷日期:2023年7月31日星期一,晚上10:07:52(美国东部时间) 作者:AlbertZhao 不公开状态 尚未正式公布:2023年8月1日 公布公开日期:2023年12月1日 DOIRef:89bb2 文档身份证:GUID-06A07B0B-3865-40B6-A4C9-D77B5DAD0B3B2en-US 文件类型:一...