- >
- Blog
- >
- Impurity profile
In 1905, George Santayana published his famous aphorism: “Those who cannot remember the past are condemned to repeat it.” More than 100 years later, this is could be an unofficial guiding principle…
A significant paradigm shift is underway in the regulatory environment for impurities in pharmaceutical products. Recent incidents involving genotoxic impurities (GTIs) are driving tighter restrictions and guidelines, as well as…
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…
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…
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…
In the pharmaceutical discovery space, many promising analytical trends have emerged and are now on the rise – and they will see increasing use in drug discovery in coming years….
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…
Sometimes I feel like I come across as a bit too “QA crazy,” but quality in the pharma sense isn’t really something of which you can have too much. From…
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…
