USP-standardized analyses with ion chromatography: Simple, efficient, and robust
The United States Pharmacopeia (USP) has updated and modernized existing monographs across all compendia to include ion chromatography (IC) methods for pharmaceutical assays and for the analysis of impurities and excipients. IC is a robust multi-parameter analysis technique that is flexible, easy to use, and suited for the determination of anions, cations, and any other kind of charged molecules.
Metrohm has partnered with the USP for ion chromatography method development and offers you robust solutions for your standardized pharmaceutical analyses. A detailed list of USP monographs that were developed and validated with Metrohm IC instruments can be found in this flyer:
Flyer: Bring your USP methods up to date! (8.000.5436, PDF, 188 KB)
USP-standardized analyses with IC
We are happy to help you:
- Validate a method
- Implement column equivalency
- Modernize or convert methods (titration or HPLC to IC)
- Search for USP-compliant Metrohm applications
USP General Chapters and monographs: Compliance using Metrohm Ion Chromatography
Metrohm Ion Chromatography (IC) systems are the ideal solution for pharmaceutical testing of Active Pharmaceutical Ingredients (APIs), impurities, and excipients.
Metrohm IC methods are fully compliant with the USP General Chapters such as:
- <1225> Validation of Compendial Procedures
- <621> Chromatography
- <1065> Ion Chromatography
- <191> Identification Tests – General
- <345> Assay for Citric Acid/Citrate and Phosphate
- <591> Zinc determination
Ion chromatography and pharmaceutical R&D
Metrohm has compiled different white papers, posters, and webinars on ion chromatography in the pharma industry. Find more information below.
White papers
USP monograph modernization leading to IC-based methods
The USP modernization initiative has led to the development of IC-focused USP monographs and General Chapters. This free white paper gives an overview of the modernization initiative and why ion chromatography has been adopted by USP on a large scale. In addition, it explains what ion chromatography is and how it overcomes limitations encountered with HPLC.
A case study on using ion chromatography in pharmaceutical R&D
This case study presents ion chromatography as a suitable analytical tool in the product development of a cell-based gene therapy.
Determination of PRP in Haemophilus influenzae vaccine
This white paper gives insights on the successful development of an analytical method for a glycoconjugate vaccine of Haemophilus influenzae.
When HPLC fails: IC in food, water, and pharmaceutical analysis
This white paper presents ion chromatography as a valuable and efficient analytical technique when HPLC fails.
Posters
Metrohm has collaborated with the USP to create the following posters:
USP Modernization Initiative: Iodide Assay by Ion Chromatography (8.000.6109, PDF, 853 KB)
Fluoride in OTC Products by Ion Chromatography (8.000.6110, PDF, 862 KB)
Potassium Assay in OTC Drug Products by Ion Chromatography (8.000.6106, PDF, 2.3 MB)
On-demand webinars
IC methods for potassium, calcium, and magnesium assays
This on-demand webinar presents validated ion chromatography methods for assay of potassium and calcium and the associated impurities. A new method to address the challenges associated with magnesium assays in various magnesium-based OTC products as well as sample preparation and automation options are also discussed.
Ion chromatography in pharmaceutical R&D
In this on-demand webinar, Zoe Yin from Sigilion Therapeutics shares how her high throughput lab developed a fit-for purpose method using Quality-by-Design (QbD) to meet internal process development needs. Zoe provides an evaluation of different techniques and discusses the payoffs associated with transitioning from outsourced ICP-MS testing to in-house implementation of ion chromatography (IC).
Analysis of impurities in pharmaceuticals using IC
This on-demand webinar explores the different kinds of impurities that may be present in pharmaceutical products and how IC is the analytical tool of choice to meet regulatory authorities’ requirements and in defining effective control strategies.
Learn how ion chromatography can help to automate impurities analysis workflows. Inline sample preparation techniques will also be discussed.
Ion chromatography and USP – Your benefits
Ion chromatography is a well established and accepted regulatory method for analyzing anions and cations in pharmaceutical drug substances and drug products.
Compared to single-parameter methods, such as titration, ion measurements, and other wet chemical procedures, ion chromatography is:
- More efficient: Multiple parameters are determined in one go
- More selective: Target analytes are clearly identified
- Safer: Hazardous procedures and materials such as solvents, reagents, and other chemicals are not required
Why Metrohm Ion Chromatography? – We make the difference
Metrohm has been developing and manufacturing ion chromatography systems for more than 30 years. Metrohm Ion Chromatography stands for:
- Robust instruments: We grant a 3-year warranty on our Swiss-made instruments and a 10-year warranty on the anion suppressor.
- Compatibility: Metrohm IC systems can be controlled by our MagIC Net software or by OpenLab CDS (Agilent), and EmpowerTM CDS (WatersTM)
- Compliance: Metrohm IC instruments comply with GLP and meet all requirements regarding data integrity, security, and traceability as per FDA 21 CFR Part 11, ALCOA, and ALCOA+.
- Professional service and support wherever you are: Metrohm is present in 40 countries with subsidiaries and in more than other 40 countries with exclusive partners.
Application Finder Learn more in our application notes for the pharmaceutical industry: |
USP & Titration Learn more about the USP recommendations to replace manual titration with autotitration and about titration method validation here: |