世界卫生组织关于化学对照品的指导原则介绍.pdf

166 Ch in J Pharm Anal 2010, 30( 1) 宁保明, 黄海伟, 张启明, 金少鸿 (, 100050) : , , 2006 ,, , : ; : R917 : A : 0254- 1793( 2010) 01- 0166- 07 Introduction ofWHO general guidelines for the establishment, maintenance and distribution of chem ical reference substances NING Bao- m ing, HUANG H ai- we,i HANG Q i- m ing, JIN Shao- hong (TheN ational Institute for the Control of Pharm aceutical and Biological Products, Beijing, 100050, China) Abstract: This updatedWHO guideline on chem ical reference substanceswas established and issued by theWHO Expert Comm ittee on Specifications for Pharm aceutical Preparations in 2007. The very first edition ofWHO guide line was published in 1975, and then reviewed andmodified in 1982 and subsequently revised in 1999. The purpose of establishing chem ical reference substances guideline is ami ed at fostering greater collaboration and harmonization among various national and regional authorities responsible for collections of chem ical reference substances, further more, the context of this guideline describe the general principles for the establishment of prmi ary and secondary chem ical reference substances, provide the technical guidance on the source of candidate, evaluation, assignment of content, m aintenance, distribution and all the relevant aspects of chem ical reference substances. The finalgoal of this guideline is to achieve accuracy and reproducibility of the analytical results required by pharmacopoeia testing and pharm aceutical control in genera.l K ey words: chem ical reference substances; guidelines [ 2] , , 1975, , WHO [ 1] ,