USP General Chapter < 1010 > on Statistical Approaches or Evaluating Data 1, 2 1, , ( ) ( 1 )( 1) where = 1,...r outliers is the 100 percentage point of the distribution with degrees of freedom and 1 2( 1) n i p i n i p p t n i n i t n i i t p t p n i ...
USPGeneralChapter<621>EPGeneralChapter<2.2.46> ColumnLength±70%±70% ColumnI.D.Nolimit,butkeepconstantlinearvelocity±25% ParticleSize-50%-50% FlowRate±50%±50% Temperature±10℃ ±10℃ Maximum60℃ InjectionVolume Acceptableaslongasitsatisfiesthesystem ...
I ndividual USP or NF monographs as well as certain General Chapters specify the USP Reference Standard(s) required for assay and test procedures. General Chapter <11> USP Reference Standards provides general informa-tion and instructions for proper use and storage. Consult the label text for...
a monograph, or a general chapter numbered below 1000. General chapters numbered above 2000 apply ...
The purpose of this chapter is to provide guidance for validating methods for use as alternatives to the official compendial microbiological methods. For microbial recovery and identification, microbiological testing laboratories sometimes use alternative test methods to those described in the general chapter...
The article focuses on the US Pharmacopeia's (USP) proposed General Chapter (1226) "Verification of Compendial Procedures". The process of validating a new analytical procedure for compendial usage is addressed in the proposed General Chapter. The article reports on USP's response to request of ...
<905>UNIFORMITY OF DOSAGE UNITS(Harmonized Chapter, Official April 1,2006)……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>WATER DETERMINATION……2785水测定法 <941>X-RAY DIFFRACTION……2788X光衍射 General Information通用信息 <1010>ANALYTICAL DATA—INTERPRETATION AND ...
欧盟EP英国BP 2013 endix XVI C,美国USP 51(USPGeneral Chapter51),欧盟化妆用品及香料协会指引COLIPA,化妆品及香料协会CTFA等。 USP51,EP7.0防腐挑战测试过程:防腐测试需进行霉菌菌种前培养,霉菌菌种前培养需要5天,再进行加菌测试,加菌后培养14天,再进行样品洗脱。