USP Monograph Modernization & Ion Chromatography Portal Brochures

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.

Brochures

Ion Chromatography for Pharma and Biopharma:
Complete IC solutions for Pharmaceuticals and Biopharmaceuticals

Discover the unique benefits of modern ion chromatography systems for the analysis of pharmaceuticals and biopharmaceuticals.

Thermo Scientific™ Dionex™ ICS-5000+ HPIC™ System

The ICS-5000+ HPIC system is a top-of-the-line IC system capable of addressing a full range of IC application needs. It is the next generation, premier ion chromatography system with the ability to operate as a Reagent-Free™ (RFIC™) system at up to 5000 psi. Its high-pressure capability gives you the flexibility to use small-particle columns in standard lengths for higher resolution without sacrificing speed or shorter (150 mm) columns for higher flow rates and high throughput.

Thermo Scientific™ Dionex™ Integrion™ HPIC™ System

Your laboratory ecosystem is different from all others. It consists of its own unique web of interactions between your laboratory team and the instruments they use. At its best, everything is in sync. Thoughtfully designed instruments accelerate your stream of results while blending seamlessly into your laboratory. The Integrion IC system is made to support you. It was designed to fit with the flow of your laboratory so that it quickly falls in sync with your processes.