All Impurities, contaminants and nitrosamines articles – Page 2
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NewsEU Urban Wastewater Treatment Directive may compromise EU medicine availability
The directive could lead to nearly €1 billion in additional costs for pharmaceutical companies in Finland alone, states Orion Corporation.
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ArticleICH Q6(R1): test criteria and specifications
Dave Elder shares industry thoughts on an ICH Q6(R1) concept paper that aims to revise general principles for uniformity and consistency across ICH Q6 guidelines for test criteria and specifications.
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NewsNew 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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ArticleMAS-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.
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ArticleUnderstanding 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.
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NewsDownstream 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).
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NewsEuropean 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.
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NewsChromatography 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.
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NewsUsing 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.
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NewsUnique 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.
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NewsResearchers 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.
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NewsAnalytical 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.
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NewsRapid 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”.
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NewsPreventing fungal contamination in pharmaceuticals
While fungal contamination detection in pharmaceutical manufacturing remains a challenge, preventive practices and policies must be followed, research states.
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ArticleForward-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).
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ArticleNitrosamines analysis with LC/MS-MS
This ebook provides a comprehensive overview of nitrosamine analysis for the pharmaceutical industry.
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NewsPharmaceutical excipients market to witness expansion
According to research, increased in R&D investment for developing novel excipients and greater emphasis on patient-centric formulations are key drivers for the pharmaceutical excipients market.
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NewsStudy reports rapid method for microbial contaminant detection
Research using fluorescent optical respirometry (FOR) illustrated successful detection of aerobic bacteria three hours after setting samples.
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NewsIndia joins mission to harmonise pharmacopoeial standards
As a “major manufacturer of the world’s medicines”, the Indian Pharmacopoeia Commission (IPC) has joined the Pharmacopoeial Discussion Group (PDG) to contribute to the harmonisation of quality standards.
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NewsIncreasing efficacy in extractables and leachable testing
Researchers have proposed a read-across methodology for pharmaceutical extractables and leachable (E&L) testing as a time-saving alternative to toxicity testing.
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