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Impurities

Setting the standard for water quality measurement and control

29 March 2019 | By SWAN Analytical Instruments

A brief overview of how SWAN Analytical Instruments helps to ensure water quality with analysers to measure trace ozone and total organic carbon (TOC).

whitepaper

Application note: Conductivity bridge study – from benchtop metre and probe to automated Sievers M9

29 March 2019 | By SUEZ

This application note discusses the desired future state for measuring conductivity of compendia water samples and how the Sievers M9 TOC Analyzer with Conductivity enables users to reach this state.

news

Three further Losartan batches recalled

26 March 2019 | By European Pharmaceutical Review

The MHRA has recalled three batches of Losartan tablets due to contamination with the nitrosamine N-nitroso-N-methylamino butyric acid...

news

FDA finds another carcinogenic impurity in ARB blood pressure drug

4 March 2019 | By Nikki Withers (European Pharmaceutical Review)

FDA is 'deeply concerned' about a third type of nitrosamine impurity detected in angiotensin II receptor blocker (ARB) medicines...

article

Elemental impurities testing and specification limits – ICH Q3D

22 December 2018 | By Dave Elder (JPAG Member and David P Elder Consultancy)

The introduction of ICH Q3D (Guideline for Elemental Impurities)1 was an additional safety-based guidance for toxic impurities that complemented the existing ICH Q3C(R5) (Impurities: Guideline for residual solvents)2 and ICH M7(R1) (Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk);3 as well as the…

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