On acceptable values of disregard limits for impurities and signal-to-noise ratio when checking chromatographic system sensitivity

On acceptable values of disregard limits for impurities and signal-to-noise ratio when checking chromatographic system sensitivity

The article provides answers to urgent questions relating to the acceptable values of disregard limits for impurities and signal-to-noise ratio ( S / N ) when checking the sensitivity of the chromatographic system. It gives recommendations on the «typical» and maximum acceptable values of disregard...

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Bibliographic Details
Main Author: N. A. Epshtein
Format: Article
Language:Russian
Published: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2018-02-01
Series:Регуляторные исследования и экспертиза лекарственных средств
Subjects:
отношение сигнал/шум
раствор для проверки чувствительности
порог игнорирования примесей
хроматографическая система
фармакопея
signal-to-noise ratio
sensitivity solution
disregard limit for impurities
chromatographic system
pharmacopoeia
Online Access:https://www.vedomostincesmp.ru/jour/article/view/124
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