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There’s an article on Piramal’s Pharma Solutions division at PharmTech about how they are encouraging pharma companies to implement green chemistry earlier in the drug development cycle. Yes, we agree…
A genotoxic impurity (GTI) is a chemical substance that can directly or indirectly damage DNA or chromosomes and induce genetic mutations. Fifteen years ago, there were no specific guidelines for…
7 ways to boost profits and reduce pharma synthesis waste At Neuland, we’re advocates of green chemistry. Not only is it better for the environment, but it’s also just logistically…
Impurities and the ICH Limits for Impurities Impurities are unwanted chemicals produced during normal manufacturing of Active Pharmaceutical Ingredients, or APIs. As you well know, impurities have no therapeutic value…
Genotoxic impurities were around long before humans first began boiling bark. Our attempts to quantify, understand and control GTI formation, however, is a much more recent phenomena. It’s also a…
Let’s face it – ‘cost-effective capabilities’ is a big reason why CROs and CMOs continue to be a highly-popular drug commercialization route of choice. Where else can you find ready-to-go…
Reducing Mutagens, Carcinogens & Other Genotoxins to Improve Safety Profiles There are a number of process modifications API manufacturers can make to improve safety profiles, reduce production costs, improve capacity…
Active Pharmaceutical Ingredients (APIs, or – in layman’s terms – the ingredients that makes drugs work) have grown increasingly complex. Today’s equivalent of boiling tree bark into a tincture typically…
Last week, we wrote a post on new analytical methods for the detection of impurities that our R&D group had developed for the drug Febuxostat. And we’ve done the same…
In this month’s issue of PharmTech, team members at Neuland’s R&D Center in Hyderabad published a peer-reviewed article on the analysis and management of impurities in the drug Febuxostat. Febuxostat, a…
