news
New mass spectrometry Chapter could “revolutionise” biopharma quality assurance
Launch of the USP general method chapter signals a breakthrough in pharmaceutical drug impurity control, according to biopharma experts.
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Impurities
article
MAS-100 Libra®: the future of continuous cleanroom monitoring
Microbiological monitoring is essential for pharmaceutical facilities. As regulatory standards tighten, especially in cleanroom classes A and B, the need for reliable, continuous monitoring has grown. The MAS-100 Libra meets these demands by combining traditional settle plate methods with advanced automation, improving efficiency and accuracy.
article
Understanding endotoxin cartridge testing: frequently asked questions
Charles River’s Courtney Wachtel and Sherri Hopple discuss endotoxin cartridge testing, its application and how it differs from traditional BET assays.
news
Downstream process shows potential for oncolytic virus purification
The paper presents an “efficient and scalable GMP-compliant process” for purifying a fusogenic oncolytic virus (rVSV-NDV).
news
European Pharmacopoeia makes milestone pyrogen testing commitment
The "historic" decision from the Ph. Eur. follows publication of its texts relating to the rabbit pyrogen test (RPT) replacement strategy.
news
Chromatography analysis for nitrosamine quantitation in pharmaceutical manufacturing water
The paper describes an innovative ion chromatography-based analytical method for quantifying nitrite quantities in purified and potable water.
podcasts
EPR Podcast Episode 26 – Navigating Nitrosamine Impurities – Jason Brown, Adare Pharma Solutions
In this podcast, Jason Brown, Senior Manager, Analytical Sciences, R&D, Adare Pharma Solutions, discusses the current landscape and the best approaches for mitigating contamination and detecting nitrosamines.
news
Using mass spectrometry to improve quality and safety of levothyroxine
A study investigating levothyroxine has reported a new non-targeted analytical approach for pharmaceutical quality control analysis.
news
Unique testing regimen could prevent nuclease contamination
Biannual routine testing in the laboratory reduces both the likelihood of nuclease contamination occurrence and its impact, a study suggests.
news
Researchers propose novel test for pyrogen detection
An alternative in vitro pyrogen detection test using transfected THP-1 cells detected endotoxin and nonendotoxin pyrogens with good sensitivity, stability and predictability, a study shows.
news
Analytical technique may advance medical cannabis quality control
Combining near-infrared spectroscopy (NIR) hyperspectral imaging (HSI) and machine learning could offer a simpler, non-invasive alternative to established analytical techniques such as chromatography, research suggests.
news
Rapid pseudomonas aeruginosa detection method developed
Research suggests the rapid detection method “will enable the timely implementation of microbiological monitoring strategies for large batches of medications”.
news
Preventing fungal contamination in pharmaceuticals
While fungal contamination detection in pharmaceutical manufacturing remains a challenge, preventive practices and policies must be followed, research states.
article
Forward-thinking CDMO tackles the dynamic challenge of N-nitrosamines control with high-performance analytical instrumentation
Poland-based Polpharma API relies on Waters analytical instrumentation for impurities method development and testing to meet the ever-evolving regulatory guidance around N-nitrosamines (nitrosamines) control in active pharmaceutical ingredients (API).
article
Nitrosamines analysis with LC/MS-MS
This ebook provides a comprehensive overview of nitrosamine analysis for the pharmaceutical industry.
