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With technology racing onward, drugs are becoming more complex than ever before – along with their active ingredients and the processes that produce them. Different Challenges, Different Scales – The…
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…
‘One hundred percent purity’ is the holy grail of pharma – and, more generally, the scientific community. Firms in our industry all around the globe spend the overwhelming majority of…
There have been a number of articles recently pointing to growth in the API industry, and it’s something I’ve discussed as well – most recently in a post on the…
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…
I’ve mentioned the importance of route scouting in the past. Now I’d like to share some of the properties of API synthesis that can affect the yield, purity, and delivery date…
It’s been nearly two years since the FDA issued their draft guidance on quality agreements and contract manufacturer management. The consensus seems to be that the FDA shifted the responsibility…
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…
The Right Route Can Deliver Fewer Steps, More Consistent Batches, Cleaner Processes…and Cost Savings With drug development and manufacturing processes becoming more complex, alternate synthetic route design is often a…
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…
