Impurities

Ion chromatography offers advantages in the analysis of counterions (anions or cations), excipients/inactive formulation components and other impurities/degradants.

Determination of Methylamine in Drug Products

Determination of Morpholine in Linezolid by Ion Chromatography

Assay of Nitrite and Determination of Nitrate Impurity in Sodium Nitrite Using a Reagent-Free Ion Chromatography System

Determination of Galactosamine-Containing Organic Impurities in Heparin by HPAE-PAD

Glycans

Glycans have no chromophore and therefore have a poor response with conventional LC-UV detection; they are commonly labeled with fluorescent tags prior to analysis by LC-fluorescence detection. HPAE-PAD is a sensitive, simpler alternative, where released N- and O- linked glycans can be directly analysed following their release, without the need for prior derivatization.

Evaluating Protein Glycosylation in Limited-Quantity Samples by HPAE-PAD

Improved Separation of Aminobenzamide (2-AB)-Labeled N-glycans from Human α1 Acid-Glycoprotein for Analysis by HPAE-FLD

HPAE-FLD Method for Separation of Human α1 Acid-Glycoprotein and Bovine Fetuin 2-Aminobenzamide (2AB)-Labeled Oligosaccharides

HPAE-PAD N-linked oligosaccharide profiling of IgG

Counterions

With more than 50% of pharmaceuticals on the market using counter ions, their analysis constitutes an essential part of drug development, QC and lot release processes to ensure patient safety and drug efficacy. 

Faster and Improved Ease-of-Use Assays of Citrate and Phosphate in Pharmaceutical Formulations Using Ion Chromatography with Suppressed Conductivity

Ion Chromatography Assay for Lithium in Lithium Hydroxide

Assay for Citrate and Phosphate in Pharmaceutical Formulations Using Ion Chromatography

Assay for Citrate and Phosphate in Pharmaceutical Formulations Using a High-Pressure Compact Ion Chromatography System

Monosaccharides & Sialic Acids

Monosaccharide and sialic acid analysis is necessary since the sugar composition can impact the safety and efficacy of a biotherapeutic. Monosaccharides are weak acids and can be directly analyzed by HPAE-PAD without the need for prior derivatization.

Monosaccharide and Sialic Acid Determinations in Biosimilars Using HPAE-PAD

Glycoprotein Monosaccharide Analysis using HPAE-PAD with Manually Prepared Eluent

Antibiotics

Like all other APIs, antibiotics require full characterization and their quality must be monitored. Some classes of antibiotics lack a chromophore, which makes HPAE-PAD a perfect solution, reflected in the increasing number of antibiotic USP monographs detailing the use of IC.

Determination of tobramycin using HPAE-IPAD on a compact ion chromatography system

Analysis of the Aminoglycoside Antibiotics Kanamycin and Amikacin Matches USP Requirements

Determination of N-Methylpyrrolidine in Cefepime Using a Reagent-Free Ion Chromatography System

Amino Acids

Amino acids, carbohydrates, glycols, alcohols, amines, and sulfur-containing compounds can be oxidized and therefore directly detected by HPAE-PAD. 

Determination of Amino Acids in Cell Cultures and Fermentation Broths