Analysis reports nitrosamine prevalence in small molecule drugs
Data from a paper on small molecule drugs has indicated nitrosamines in pharmaceuticals is likely more prevalent than originally expected.
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Data from a paper on small molecule drugs has indicated nitrosamines in pharmaceuticals is likely more prevalent than originally expected.
A data-driven approach to optimise sanitisation and improve process control of the microbial parameter in a water system.
In this edition, experts from Institute of Biomedical Research Antoine Marxer and Associates of Cape Cod International share insight on endotoxin testing.
EPR Issue 2 includes articles on the future of cell and gene therapy, the potential of AAV gene therapies, NMR relaxometry and more…
A paper states ATR-FT-IR spectroscopy plus multivariate analysis for heparin analysis is cost-effective compared to NMR.
Researchers have developed a new automated buffer management system that offers supply to continuous downstream process for 10 days with consistent quality.
Microbiology expert Tim Sandle’s recent video examined identifying the origin of fungi in pharmaceutical cleanrooms.
A new version of an open-source software is the first tool with an entire data processing pipeline that integrates LC-IMS-MS and MALDI-IMS-MS imaging data.
While determining active intakes and control strategies for short chain alkyl N-nitrosamines was relatively easy to establish, nitrosamine drug substance-related impurities continue to present challenges. Here, Dave Elder reflects on the three main instances of nitrosamine contamination in drug products.
US Pharmacopeia (USP) and American Type Culture Collection (ATCC) will collaborate to better support the biologics sector in R&D, process development and release of high-quality biologics.
A report reviewing the state of sterile oligonucleotide drug processing has recommended ways to aid development of terminal sterilisation processes.
Researchers have shown a combination of peracetic acid and ultraviolet light could improve microbial water quality in pharmaceutical water systems.
Research suggests that the global sterility testing market will see a nearly $200 billion increase in spending on new products in the next five years.
This ebook takes an in-depth look at advanced analytical methods for extractables and leachables analysis in the pharma industry.
Key stakeholders in the medicine supply chain have been urged by the World Health Organization to take immediate action against recent cases of contaminated medicines.