標(biāo)準(zhǔn)解讀 | 美藥典 USP<831> 折光最新解讀

變更內(nèi)容：

新版藥典明確折光儀需要三個認(rèn)證：安裝確認(rèn)(IQ)、操作確認(rèn)(OQ)和性能確認(rèn)(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〉.”

安東帕解決方案：

安東帕折光儀擁有規(guī)范的4 Q -制藥資質(zhì)包 (PQP) ，完整覆蓋 IQ, OQ 和 PQ，同時 還具備 " 資格確定計劃" ，"風(fēng)險分析 " 和 "資格確定說明 "的認(rèn)證服務(wù)內(nèi)容。

變更內(nèi)容：

新版藥典明確折光儀需要滿足以下內(nèi)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)”

安東帕解決方案：

安東帕折光儀用于折射率和濃度的常規(guī)質(zhì)量控制測量，精度為+/-0.0001 nD，遠(yuǎn)超標(biāo)準(zhǔn)。

Abbemat可依據(jù)USP 831使用客戶參考樣品考察準(zhǔn)確度和重復(fù)性。