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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Type Title Test Column Resource #
Brochure  Ion Chromatography for Pharma and Biopharma Various  BR72257
Application Note  Assay for Citrate and Phosphate in Pharmaceutical Formulations Using a High-Pressure Compact Ion Chromatography System Assay IonPac AS11  AU205
Application Note  Determination of tobramycin using HPAE-IPAD on a compact ion chromatography system Assay, impurity CarboPac PA1  AU72197
Application Note  Faster and Improved Ease-of-Use Assays of Citrate and Phosphate in Pharmaceutical Formulations Using Ion Chromatography with Suppressed Conductivity Assay IonPac AS11  PN72097
Application Note  Determination of Methylamine in Drug Products Impurity IonPac CS19  AN1057
Presentation  Increasing Importance of Ion Chromatography for Pharmaceutical Analysis Various
Application Brief  Assay for Citrate and Phosphate in Pharmaceutical Formulations Using a Compact IC System Assay IonPac AS11  AB71920
Application Note  Assay for Citrate and Phosphate in Pharmaceutical Formulations Using Ion Chromatography Assay IonPac AS11  AN71941
Application Brief  Assay for Lithium, Sodium, and Calcium in Lithium Carbonate Using a Compact Ion Chromatography System Assay IonPac CS16  AB71919
Application Note  Assay of Nitrite and Determination of Nitrate Impurity in Sodium Nitrite Using a Reagent-Free Ion Chromatography System Assay, impurity IonPac AS12A  AN71893
Application Note  Determination of Ammonia in Sodium Bicarbonate Impurity IonPac CS16  AN70815
Application Brief  Determination of Ammonia in Sodium Bicarbonate Using a Compact Ion Chromatography System Impurity IonPac CS16  AB71921
Application Note  Determination of Benzenesulfonic Acid Counterion in Amlodipine Besylate by Ion Chromatography Counterion IonPac AS18  AN70907
Application Brief  Determination of Inorganic Counterions in Pharmaceutical Drugs Using Capillary IC Counterion IonPac AS19  AB70454
Application Brief  Determination of Sulfate and Sulfamate in Topiramate Using a Compact Reagent-Free Ion Chromatography System Assay IonPac AS11  AB71934
Poster Note  Determination of Sulfate Counter Ion and Anionic Impurities in Aminoglycoside Drug Substances by Ion Chromatography with Suppressed Conductivity Detection Counterion, impurity IonPac AS18  LPN 2019-01
Application Note  Determination of Tartaric Acid in Tolterodine Tartrate Drug Products by IC with Suppressed Conductivity Detection Counterion IonPac AS20, IonPac AS22  AN1002
Poster Note  IC Assay for Lithium in Lithium Citrate Assay, impurity IonPac CS12A  PN71825
Poster Video  IC Assay for Lithium in Lithium Citrate Assay, impurity IonPac CS12A
Application Brief  IC Assay for Lithium, Sodium, and Calcium in Lithium Carbonate Assay, impurity IonPac CS16  AB71919
Webinar  IC Assay Methods for Impurities, Degradation Products, and Counterions in Drug Substances and Drug Products Impurity Various
Application Note  Implementation of a Walk-Up High-Pressure Capillary Ion Chromatograph for the Fast Separation of Pharmaceutical Relevant Inorganic Anions and Cations Impurity Various  AN2967
Application Note  Ion Chromatography Assay for Lithium in Lithium Citrate Assay IonPac CS12A  AN71522
Application Note  Ion Chromatography Assay for Lithium in Lithium Hydroxide Assay, impurity IonPac CS16  AN71807
Application Note  Assay for Citrate and Phosphate in Pharmaceutical Formulations Using Ion Chromatography Assay IonPac AS11  AN71941