标准解读 | 美药典 USP 折光最新解读

变更内容：

新版药典明确折光仪需要三个认证：安装确认(IQ)、操作确认(OQ)和性能确认(PQ)。

“Qualification of refractometers can be divided into three elements: installation qualification (IQ), operational qualification (OQ), and performance qualification(PQ). For further discussion, see Analytical Instrument Qualification 〈1058〉.”

安东帕解决方案：

安东帕折光仪拥有规范的4 Q -制药资质包 (PQP) ，完整覆盖 IQ, OQ 和 PQ，同时 还具备 " 资格确定计划" ，"风险分析 " 和 "资格确定说明 "的认证服务内容。

变更内容：

新版药典明确折光仪需要满足以下内容：

“The apparatus should provide refractive index readings to ±0.0001…” 

“…The certified reference materials used must have an equal or better expanded uncertainty than ±0.001.”

“Verify the repeatability of the refractometer by measuring at least two different certified reference materials covering the intended operational range of the instrument. Perform at least six replicate measurements of each certified reference material. The result should be equal to or less than the stated repeatability performance specification of the instrument (as provided by the manufacturer)”

安东帕解决方案：

安东帕折光仪用于折射率和浓度的常规质量控制测量，精度为+/-0.0001 nD，远超标准。

Abbemat完全可依据USP 831使用客户参考样品考察准确度和重复性。