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We’ve recently written extensively about nitrosamine impurities, including this in-depth analysis of what transpired with Valsartan, and some follow-up material, here and here. Nitrosamine impurities have been receiving a great…
Following up on our earlier post on the 2018 valsartan contamination, much has happened over the last six months. In our original post, we discussed the appearance of impurities in…
Why is there a growing preoccupation with particle size? It’s because particle size can alter the efficacy (e.g., bioavailability) and safety profile (e.g., toxicity) of a compound. Complex particle sizing…
Rise of the Peptide Era Peptide synthesis has a long pharmaceutical history, stretching back to the early 1900s – and then followed by a lengthy period of dormancy….
We’ve reached the two year anniversary of the first FDA approval of a deuterated molecule (April 2017, Teva’s Astedo – a deuterated version of tetrabenazine for the treatment of Huntington’s…
The first in the class of drugs known as selective relaxant binding agents (SRBA), Sugammadex sodium is used to reverse anesthesia. Via 1:1 binding of rocuronium or vecuronium, it rapidly…
Drug manufacturing technology transfer is one of the most complicated and demanding processes in the drug company-contract development organization relationship. There is one overriding deliverable that must go right –…
Some drugs and APIs are more challenging to produce than others – and Propofol is an excellent example. If the name Propofol rings a bell, it’s likely because the drug…
Properties which can affect an API’s yield, delivery date and purity include: Type of Synthesis Propinquity Complexity of Structure Cost Efficient Synthesis Carryover of impurities into drug substance Minimum isolation…
In recent posts on the topic of Quality by Design and drug manufacturing, we referenced (here, here and here) the importance of being able to reduce unanticipated challenges by developing…
