Impurities

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

Impurities_App1.png

Determination of Methylamine in Drug Products

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Impurities_App2.pngDetermination of Morpholine in Linezolid by Ion Chromatography


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Impurities_App3.pngAssay of Nitrite and Determination of Nitrate Impurity in Sodium Nitrite Using a Reagent-Free Ion Chromatography System

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Impurities_App4.pngDetermination of Galactosamine-Containing Organic Impurities in Heparin by HPAE-PAD

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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.

Glycan_App1.pngEvaluating Protein Glycosylation in Limited-Quantity Samples by HPAE-PAD

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Glycan_App2.pngImproved Separation of Aminobenzamide (2-AB)-Labeled N-glycans from Human α1 Acid-Glycoprotein for Analysis by HPAE-FLD

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Glycan_App3.pngHPAE-FLD Method for Separation of Human α1 Acid-Glycoprotein and Bovine Fetuin 2-Aminobenzamide (2AB)-Labeled Oligosaccharides

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Glycan_App4.pngHPAE-PAD N-linked oligosaccharide profiling of IgG

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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. 

Counterions_App1.pngFaster and Improved Ease-of-Use Assays of Citrate and Phosphate in Pharmaceutical Formulations Using Ion Chromatography with Suppressed Conductivity

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Counterions_App2.pngIon Chromatography Assay for Lithium in Lithium Hydroxide

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Counterions_App3.pngAssay for Citrate and Phosphate in Pharmaceutical Formulations Using Ion Chromatography

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Counterions_App4.pngAssay for Citrate and Phosphate in Pharmaceutical Formulations Using a High-Pressure Compact Ion Chromatography System

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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.

Glycan1.pngMonosaccharide and Sialic Acid Determinations in Biosimilars Using HPAE-PAD

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Monosacc_App2.pngGlycoprotein Monosaccharide Analysis using HPAE-PAD with Manually Prepared Eluent

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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.

Antibiotics_App1.pngDetermination of tobramycin using HPAE-IPAD on a compact ion chromatography system

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Antibiotics_App2.pngAnalysis of the Aminoglycoside Antibiotics Kanamycin and Amikacin Matches USP Requirements

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Antibiotics_App3.pngDetermination of N-Methylpyrrolidine in Cefepime Using a Reagent-Free Ion Chromatography System

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Amino Acids

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

AminoAcids_App1.pngDetermination of Amino Acids in Cell Cultures and Fermentation Broths

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