标准品的分级如何识别一级还是二级
QC注册申报分析方法GMPQC和物料分册

依据中国药典通则0291,标准品分为一级国家标准物质和二级国家标准物质,而在中检院购买的标准品说明书中无法识别出,该如何判别?

2025-08-06 16:57 U1660799439     
3个回答

根据国家市场监管总局2020年发布的《标准物质管理办法》内容:

  第六条 标准物质的定级条件:
  (一)一级标准物质
  1.用绝对测量法或两种以上下同原理的准确可靠的方法定值。在只有一种定值方法的情况下,用多个实验室以同种准确可靠的方法定值;
  2.准确度具有国内最高水平,均匀性在准确度范围之内;
  3.稳定性在一年以上或达到国际上同类标准物质的先进水平;
  4.包装形式符合标准物质技术规范的要求。
  (二)二级标准物质
  1.用与一级标准物质进行比较测量的方法或一级标准物质的定值方法定值;
  2.准确度和均匀性未达到一级标准物质的水平,但能满足一般测量的需要;
  3.稳定性在半年以上,或能满足实际测量的需要;
  4.包装形式符合标准物质技术规范的要求。

  基于该文件规定,需通过标准物质定级鉴定申请,给与《国家标准物质定级证书》,其中一级标准物质代号为 “GBW” 冠于编号前部。二级标准物质代号是以 “GBW(E)” 冠于编号前部。

  但实际查看中检院对照品,标签及说明书无法查阅到相关资料信息。

  查阅识林上《国家药品标准物质管理办法(草案)》国家药品标准物质管理办法 中检院 | 2011-09-26《国家药品标准物质技术规范》

国家药品标准物质的标定及定值方法,应遵照国家药品标准、中检院发布的《国家药品标准物质技术规范》以及具体类别标准物质定值方法的要求”,实际实施过程中,并未执行申请标准物质定级鉴定的工作。

第二十二条 国家药品标准物质委员会对药品标准物质报告从研制计划、原(材料)选择、制备方法、标定方法、标定结果、数据统计分析、定值准确性、稳定性等方面进行审核,并做出可否作为国家药品标准物质的结论。中检院标准物质主管领导批准后,方可进行外包装、供应与使用。”说明批准申请后,仅做出是否为国家药品标准物质的结论,并不会进行一级和二级国家药品标准物质的分级判断,该项工作的权级为市场监管总局计量司所有。

附一级和二级标准物质申请流程

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

2025-08-10 17:39 铅笔小旧     

1、一级标准物质代号为 “GBW” 冠于编号前部。二级标准物质代号是以 “GBW(E)” 冠于编号前部。可通过查看标准品标签或说明书上的编号来判断其级别。

2、结合标准品说明书中提供的定值相关信息:若标准品采用绝对测量法或两种以上不同原理的准确可靠的方法定值,或在只有一种定值方法的情况下,由多个实验室以同种准确可靠的方法定值,则可能是一级标准物质。若采用与一级标准物质进行比较测量的方法或一级标准物质的定值方法定值,则可能是二级标准物质。

2025-08-07 10:50 Jyolo     

一级标准品(对照品)

定值方式:由中检院采用绝对测量法(如重量法、容量法等)或多种不同原理的准确可靠方法定值,定值结果具有最高准确性。
溯源性:直接溯源至国际单位(SI)、国际标准品(如 WHO 标准品)或国家基准,是国内该类标准品的 “源头”。
用途:主要用于校准二级标准品、仲裁检测、方法验证等高精度场景,或作为国家级量值传递的基准。
二级标准品(对照品)
定值方式:通过与一级标准品进行比对测量(即相对测量法)定值,其准确性低于一级标准品,但满足常规检测需求。
溯源性:间接溯源至一级标准品或国际标准品,通过一级标准品校准后确定量值。
用途:用于日常检验检测、产品质量控制、实验室内部校准等常规场景,是实际检测中最常用的标准品。


中检院标准品编号通常包含 “对照品” 字样,一级标准品可能带有 “基准”“国际溯源” 等标识(如部分生物制品的国际标准品等同物),

二级标准品则以常规编号为主(如 “中检所对照品 XXXX 号”)。


一级标准品说明书中会明确标注 “一级对照品”“溯源至国际标准”“采用绝对法定值” 等信息。
二级标准品说明书会注明 “二级对照品”“通过与一级对照品比对定值” 等内容,且定值不确定度通常大于一级标准品。


一级标准品 国家标准制定、方法验证、仲裁检测
二级标准品 日常检验、生产过程控制、实验室内部质控

2025-08-07 08:48 阳光蒲照