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Raman spectroscopy – a promising alternative approach for sterility testing
Study combining Raman spectroscopy with PLS-DA multivariate analysis achieves fast and non-invasive detection of contaminated drug products within vials.
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Impurities
![Metformin 500mg white tablets on white background [Credit: LeviMax/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Metformin-nitrosamines-300x278.jpg)
![Metformin 500mg white tablets on white background [Credit: LeviMax/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Metformin-nitrosamines-e1654079013697.jpg)
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Majority of metformin drugs have acceptable nitrosamine levels, finds study
With recalls on metformin products containing nitrosamines ongoing, a study suggests >80 percent of metformin APIs and final drug products are within safe limits.
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Advancing extractables and leachables testing
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.
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Quality-driven solutions from discovery to commercialisation
Find out how SGS’s high-quality analytical testing solutions could benefit all phases of your drug development programmes, from discovery through commercialisation.
news
Teva recalls one lot of IDArubicin Hydrochloride Injection USP
Lot 31329657B of Teva’s IDArubicin Hydrochloride Injection USP 5mg/5ml vials is being recalled across the US due to particulates.
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Pfizer recalls a further Accuretic tablet batch due to nitrosamines
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.
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Terahertz light could enhance QC of chiral drugs
A study shows terahertz light creates twisting vibrations in biomolecules, enabling the analysis of their compositions and structures.
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Blood pressure tablets recalled due to high levels of nitrosamine
Pfizer is voluntarily recalling Accuretic tablets and two generic high blood pressure treatments, due to levels of nitrosamine above ADI.
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Event review: The Future of QA/QC for Complex Biologics
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…
whitepaper
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.
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Future proofing risk assessment: preventing the next nitrosamine incident
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.
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Less than lifetime limits for N-nitrosamine mutagenic impurities
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.
news
New mass spectrometry technique to detect low-level host cell proteins
Host cell protein-automated iterative mass spectrometry (HCP-AIMS) enables the robust, reproducible and high throughput analysis of host cell proteins, says study.
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Membrane technologies to be critical in intensifying downstream bioprocessing
Experts suggest membrane-based technologies could become a vital component in end-to-end intensified bioprocesses for monoclonal antibodies.
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Metformin oral solution recalled due to nitrosamine impurity
A Class 2 recall notice for one batch of Rosemont Pharmaceuticals metformin hydrochloride 500mg/5ml oral solution has been issued by the MHRA.
