Many existing pharmaceutical and biopharmaceutical assays are time consuming, labor-intensive, involve hazardous chemicals, require extensive analyst training, and may yield significant measurement errors.
In 2011 the USP embarked on a monograph modernization initiative, aligned with the methods in other pharmacopeias, the International Conference on Harmonization (e.g., ICH Q3A and Q3B), and current FDA guidance. Ion chromatography (IC) plays a key role in drug monograph modernization because it offers a significant improvement to existing active pharmaceutical ingredient, impurity and counterion assays, with advantages in speed, reproducibility, accuracy, safety and cost-effectiveness.
This learning portal, produced in collaboration with Thermo Fisher Scientific, provides learning content, advice and guidance for the transition to modernized pharmacopoeial methods using IC. Learning content available on this microsite includes:
- Website Resources
- Strengthen your analysis of counterions, excipients and/or inactive
- Improve your understanding of impurities/degradants, antibiotics and
- Learn how cell culture media/fermentation broths, glycans and/or
monosaccharides and sialic acids are key to your analytical success
To access the microsite, complete the form opposite.