一、常见问题分析1.对照品与标准品概念不清国际标准化组织关于标准样品制备者一般能力要求的指导原则中论述药典标准物质(标准品和对照品)由药典主管机构按照本指南的一般原则建立并发放的规定,《中国药典》2010年版一部凡例中对照品系指用于鉴别、检查、含量测定和校准/检定仪器性能的标准物质,而《中国药典》2010年版二部凡例中标准品系指用于生物检定、 I. Common Problem Analysis 1. Definitions of reference substance and standard substance are unclear. ISO Guideline on General Ability Requirements of Standard Sample Preparation Discusses that pharmacopoeial reference substances (standard and reference substance) Principle established and issued by the provisions of the “Chinese Pharmacopoeia” 2010 edition of a reference case refers to the identification, inspection, content determination and calibration / verification instrument performance standards, and the “Chinese Pharmacopoeia” 2010 edition of the two examples of the standard Product means used for biological test,