USP Monograph Modernization & Ion Chromatography Portal Blogs

USP Monograph Modernization & Ion Chromatography Portal

A monograph is a written document, or standard, that describes an item (e.g., a finished drug, a drug ingredient, impurity or excipient). Many of the existing pharmaceutical and biopharmaceutical assays (e.g., those from the United States Pharmacopeial Convention [USP], and other pharmacopeias) are time consuming, labor-intensive, involve hazardous chemicals, require extensive analyst training, and may yield significant measurement errors. In recognition of this the USP embarked on a monograph modernization initiative, aligned with the methods in other pharmacopeias and 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.

Latest Blogs

Talking About My Eluent Generation – Modernizing the USP with Modern Ion Chromatography

by Gemma Ellison
Do you remember the good old days? When life was “simple”? When telephones were attached to the wall and you had to actually wind down your car windows and sat nav was a street map or three. Remember when you had to get up off the couch to turn the TV over and what do you mean there were only 4 channels to watch?! Oh wasn’t it great back then...

Modernizing the Pharmaceutical Applications Library

by Monika Verma
My previous blog titled 'When Drones Deliver Your Prescription Medications' had briefly touched upon on how modern day technology (e.g., drones!) is enabling fast and reliable service for today’s consumers. Just recently, I started to rack my brain on when this high tech boom really started to take off...

Pharmacopeial Modernization Made Easy

by Dr Rowan Moore
Back in the 80s and early 90s we used pens and paper at school. We referred to text books and went to the library or spoke to our elders to find out answers for our homework. Only last week I was invited to my 7-year-old’s school to discuss ‘phonics’ and ways of helping our children to pass their upcoming government-mandated tests...

Join the Mass Movement Towards Mass Spectrometry

by Monika Verma
A powerful connection forms when ion chromatography is coupled to mass spectrometry. As most of us are aware, achieving a comprehensive understanding of samples can be a challenge. Mass spectrometry can help an ion chromatographer gain greater insights from their samples by providing higher sensitivity and/or chromatographic peak confirmation using the mass-to-charge ratio...

10 Pharma New Year’s Resolutions You Can Keep

by Dr Rowan Moore
I wanted to share with you my ten resolutions to try and stay one step ahead of the fast-paced world of pharma and biopharma. Without further ado, let’s start the 2017 resolution charts!