Drug Monographs and Assays using Ion Chromatography

Modern methods for modern times

In 2011, the U.S. Pharmacopeia (USP) conducted a survey of the international pharmaceutical industry to evaluate existing procedures for the identification of ions and counterions in drug salts. After finding that spectrophotometric tests were the method most commonly being used, the USP undertook an initiative to modernize existing monographs across all compendia. Survey respondents preferred instrumental tests rather than traditional wet-chemistry tests, and expressed an interest in clarification of procedures and acceptance criteria. In addition to meeting these needs, modernizing the monographs will facilitate harmonizing tests with other pharmacopeias, and will enable more rigorous identification tests to decrease adulteration and counterfeiting of drugs.


Advantages of ion chromatography

Existing assays are time consuming, labor-intensive, involve hazardous chemicals, require extensive analyst training, and may yield significant measurement errors. Ion chromatography (IC) offers a significant improvement to these assays, offering the following advantages:

  • Speed: IC can simultaneously determine multiple anions or cations in a single injection.
  • Reproducibility: IC often uses electrolytically-generated mobile phases (i.e. no manual mobile phase preparation), which simplifies the method and enhances method reproducibility within and between laboratories.
  • Accuracy: IC often demonstrates detection limits well below the limits set in the USP monograph.
  • Safety: IC can robustly measure multiple analytes without staff handling hazardous reagents.
  • Cost-effectiveness: IC uses mobile phases that do not require expensive reagents or pH adjustments.

Ion Chromatography Cost Savings Calculator

USP General Chapters

  • <1065> Ion Chromatography
  • <191> Identification Tests - General
  • <345> Assay for Citric Acid/Citrate and Phosphate
  • <1225> Validation of Compendial Methods
  • <591> Zinc determination

When it comes to IC instrumentation there are a range of technologies available for pharmaceutical applications, including:

  • Modular IC systems that allow you to choose from a wide variety of chemistries, detectors, and automation options to fit your advanced application needs.
  •  Integrated IC systems that feature the reliability you need at the lowest operating cost. Equipped with whole system monitoring and a simplified plumbing layout, even those who are new to IC can quickly become seasoned users.

On either system you'll also save time and improve reproducibility with precise, automatic mobile phase generation and sample preparation.

Speak to a Sales Specialist about Pharmacopeial Modernization


Featured IC learning content

Whiteboard video

Learn the basics of ion chromatography, including an introduction to the Dionex Integrion HPIC system.

Whiteboard video

This whiteboard video discusses the role of eluents and eluent generation in separating compounds via ion chromatography.


Featured videos

Modernized IC assays and applications

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TypeTitleTestColumnResource #
Brochure Ion Chromatography for Pharma and BiopharmaVarious BR72257
Application Note Assay for Citrate and Phosphate in Pharmaceutical Formulations Using a High-Pressure Compact Ion Chromatography SystemAssayIonPac AS11 AU205
Application Note Determination of tobramycin using HPAE-IPAD on a compact ion chromatography systemAssay, impurityCarboPac PA1 AU72197
Application Note Faster and Improved Ease-of-Use Assays of Citrate and Phosphate in Pharmaceutical Formulations Using Ion Chromatography with Suppressed ConductivityAssayIonPac AS11 PN72097
Application Note Determination of Methylamine in Drug ProductsImpurityIonPac CS19 AN1057
Presentation Increasing Importance of Ion Chromatography for Pharmaceutical AnalysisVarious
Application Brief Assay for Citrate and Phosphate in Pharmaceutical Formulations Using a Compact IC SystemAssayIonPac AS11 AB71920
Application Note Assay for Citrate and Phosphate in Pharmaceutical Formulations Using Ion ChromatographyAssayIonPac AS11 AN71941
Application Brief Assay for Lithium, Sodium, and Calcium in Lithium Carbonate Using a Compact Ion Chromatography SystemAssayIonPac CS16 AB71919
Application Note Assay of Nitrite and Determination of Nitrate Impurity in Sodium Nitrite Using a Reagent-Free Ion Chromatography SystemAssay, impurityIonPac AS12A AN71893
Application Note Determination of Ammonia in Sodium BicarbonateImpurityIonPac CS16 AN70815
Application Brief Determination of Ammonia in Sodium Bicarbonate Using a Compact Ion Chromatography SystemImpurityIonPac CS16 AB71921
Application Note Determination of Benzenesulfonic Acid Counterion in Amlodipine Besylate by Ion ChromatographyCounterionIonPac AS18 AN70907
Application Brief Determination of Inorganic Counterions in Pharmaceutical Drugs Using Capillary ICCounterionIonPac AS19 AB70454
Application Brief Determination of Sulfate and Sulfamate in Topiramate Using a Compact Reagent-Free Ion Chromatography SystemAssayIonPac AS11 AB71934
Poster Note Determination of Sulfate Counter Ion and Anionic Impurities in Aminoglycoside Drug Substances by Ion Chromatography with Suppressed Conductivity DetectionCounterion, impurityIonPac AS18 LPN 2019-01
Application Note Determination of Tartaric Acid in Tolterodine Tartrate Drug Products by IC with Suppressed Conductivity DetectionCounterionIonPac AS20, IonPac AS22 AN1002
Poster Note IC Assay for Lithium in Lithium CitrateAssay, impurityIonPac CS12A PN71825
Poster Video IC Assay for Lithium in Lithium CitrateAssay, impurityIonPac CS12A 
Application Brief IC Assay for Lithium, Sodium, and Calcium in Lithium CarbonateAssay, impurityIonPac CS16 AB71919
Webinar ImpurityVarious 
Application Note Implementation of a Walk-Up High-Pressure Capillary Ion Chromatograph for the Fast Separation of Pharmaceutical Relevant Inorganic Anions and CationsImpurityVarious AN2967
Application Note Ion Chromatography Assay for Lithium in Lithium CitrateAssayIonPac CS12A AN71522
Application Note Ion Chromatography Assay for Lithium in Lithium HydroxideAssay, impurityIonPac CS16 AN71807
Application Note Assay for Citrate and Phosphate in Pharmaceutical Formulations Using Ion ChromatographyAssayIonPac AS11 AN71941
Smart Note Rapid Analysis of Critical Electrolytes and Impurities in Dialysis SolutionsAssayVarious SN37707
Application Note Determination of Inorganic Anion Impurities in a Water-Insoluble Pharmaceutical by Ion Chromatography with Suppressed Conductivity Detection AN220
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