All Impurities, contaminants and nitrosamines articles – Page 2
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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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ArticleDeveloping an effective contamination control strategy
A key part of Annex 1, due to come into effect on 25 August 2023, is the development of a holistic contamination control strategy (CCS). In this article, EPR’s Caroline Peachey summarises an expert panel discussion, which explored common challenges in implementing a CCS and made several recommendations.
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NewsNovel strategy could facilitate rapid online-endotoxin monitoring
An innovative, chemosensor-based method for detection of lipopolysaccharide (LPS) is set to facilitate development of a rapid online-endotoxin monitor.
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ArticleNitrosamines: the beginning of the end?
Dave Elder explores evolving concerns surrounding nitrosamine-related impurities while calling for continued collaboration to harmonise regulatory approaches.
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NewsEuropean regulatory perspective on nitrosamine mitigation strategies
With nitrite concentration in excipients being a key risk factor in nitrosamine drug substance related impurities (NDSRI) formation, there is opportunity to implement corrective and preventative actions (CAPAs), EMA experts say.
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NewsRevised Annex 1 now effective
The much-anticipated Annex 1 revision is finally operational; manufacturers in the EU must be compliant with the GMP guideline updates when manufacturing sterile medicinal products.
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NewsFDA warning letters highlight CAPA concerns
Several FDA warning letters distributed to pharmaceutical manufacturers in 2023 have warned of numerous corrective and preventive action (CAPA) compliance concerns.
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NewsNew European monograph for Cannabis flower adopted
The European Pharmacopoeia (Ph. Eur.) Commission's new European monograph for Cannabis flower will enter into force in July 2024.
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