Dave Elder looks at the guidelines drug manufacturers should follow to reduce nitrosamine impurities, following several recent withdrawals.
List view / Grid view
Researchers find that heparin affinity chromatography (HAC) produces highly pure extracellular vesicles with greater recovery than existing purification methods.
Study combining Raman spectroscopy with PLS-DA multivariate analysis achieves fast and non-invasive detection of contaminated drug products within vials.
With recalls on metformin products containing nitrosamines ongoing, a study suggests >80 percent of metformin APIs and final drug products are within safe limits.
With comment from Diane Paskiet, chair of the Product Quality Research Institute (PQRI) L&E Working Group, EPR’s Hannah Balfour outlines three key exposure-based safety thresholds and explores how the new extractables and leachables (E&Ls) strategy for parenteral drug products was established.
Find out how SGS’s high-quality analytical testing solutions could benefit all phases of your drug development programmes, from discovery through commercialisation.
Lot 31329657B of Teva’s IDArubicin Hydrochloride Injection USP 5mg/5ml vials is being recalled across the US due to particulates.
Batch number DD4842 of Pfizer’s Accuretic 10/12.5 mg film-coated tablets is being recalled in the UK to the pharmacy and wholesaler level.
Pfizer is voluntarily recalling Accuretic tablets and two generic high blood pressure treatments, due to levels of nitrosamine above ADI.
On 30 November and 1 December 2021, European Pharmaceutical Review hosted its first ever event – The Future of QA/QC for Complex Biologics Online Summit. Bringing together more than 600 attendees, 15 expert speakers and Thermo Fisher Scientific and Merck as sponsors, the summit gave industry experts the chance to…
Application note: Comprehensive fractionation of herbal medicine components by PDA-ELSD-triggered preparative LC
This article introduces a comprehensive fractionation method for both UV absorbing and non-UV absorbing compounds.
The valsartan nitrosamine contamination issue was probably the most significant quality issue to hit the pharmaceutical industry in a decade. Here, Dave Elder outlines how agencies and manufacturers are dealing with the problem and indicates the knowledge gaps that might be concealing future complications.
Here, Dave Elder discusses the determination of less than lifetime (LTL) limits for highly potent N-nitrosamine compounds and how to ensure safety in dosing.
Host cell protein-automated iterative mass spectrometry (HCP-AIMS) enables the robust, reproducible and high throughput analysis of host cell proteins, says study.