Keyword: standards

Applications

ion chromatography

Published case study of analytical quality by design method development and validation

Diduco has published a scientific peer-reviewed case study on how modern analytical method development can be performed in the pharmaceutical industry. The work was performed according to quality by design (QbD) principles to establish the design space and robust setpoint of the ion chromatography assay, and then validated according to the guidelines established by the International Council for Harmonization (ICH).

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Ion chromatography of five inorganic anions with and without XAMS suppressor formatted
ion chromatography

Comparing suppressed and non-suppressed ion chromatography

Suppressed ion chromatography with conductivity detection is a powerful and sensitive technique to analyse charged ionic species, especially anions of strong acids. The chemically regenerated membrane suppressor Xenoic® XAMS can enable analysis of such anions down to levels of a few microgram per litre (part per billion, ppb).

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Amino acids by gradient HILIC-ELSD and TSKgel Amide-80
HILIC

Separation of selected amino acids

Amino acids are the fundamental building blocks of all proteins and therefore essential constituents of many nutritional supplements and can also be present in pharmaceutical formulations. Due to the highly hydrophilic nature and zwitterionic charge at neutral pH of many amino acids and their structurally related degradation products, hydrophilic interaction chromatography is an attractive mode of separation that require no derivatization, while evaporative light scattering enables rather sensitive detection of these poorly light-absorbing compounds.

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Simple carbohydrates by HILIC-ELSD and Luna Omega Sugar
HILIC

Separation of simple sugars and carbohydrates

Simple carbohydrates are frequent ingredients in drinks, food, dietary supplements and pharmaceutical formulations. One approach to their analysis is hydrophilic interaction chromatography combined with evaporative light scattering detection, although this might be challenging due to the possibility of reducing sugars to mutarotate and thereby change their conformation into other anomers with different retention.

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Nucleosides and nucleobases on ZIC-cHILIC column and Agilent system
HILIC

Separation of nucleosides and nucleobases

Being one of the basic components of all cells as building blocks of DNA and RNA, there is a high and growing need for bioanalytical methods to determine nucleosides, nucleobases and related compounds in a variety of samples. Hydrophilic interaction chromatography is one of the most suitable approaches for this, due to the hydrophilicity of these compounds as demonstrated by their negative logP and logD values.

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Cascade reaction monitoring
reversed-phase

Reaction monitoring of enzyme-catalysed one-pot cascade synthesis

The move towards a more sustainable world includes sourcing functional monomers for polymer synthesis from renewable natural products rather than from fossil-based sources. This green chemistry revolution often relies on the development of new reaction procedures efficiently catalysed by enzymes to involve fewer harmful chemicals.

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Foscarnet assay calibration with XAMS suppressor and ASUREX-A200
ion chromatography

Modernized assay for foscarnet following ICH guidelines

New assay for the antiviral medication foscarnet which is a DNA polymerase inhibitor that is used to combat herpes viruses, including drug-resistant cytomegalovirus, and to treat patients with HIV as part of salvage therapy. This assay was developed by Diduco to meet the requirements in the ICH guidelines, as a contribution to the United States Pharmacopoeia initiative for modernized monograph methods.

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ion chromatography

Analysis of clodronate related substances according to European Pharmacopoeia monograph

Official quality control method for the first-generation bisphosphonate clodronate, which inhibits bone resorption and is used to treat bone weakness or pain caused by cancer that has spread to the skeleton. This analysis was performed according to the European Pharmacopoeia monograph method which is used to determine related substances that could be present as impurities in the active ingredient.

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Pharamaceutical counterions with XAMS suppressor and ASUREX-A200
ion chromatography

Generic method for isocratic separation of fifteen common pharmaceutical counterions

Many medicines and dietary supplements are bases that carry a positive charge, and these small molecules are consequently accompanied by negatively charged counterions. Such anionic excipients may influence the properties of the pharmaceutical formulation and can also influence the effect of the active ingredient since different ion pairs can have different dissolution rates or abilities to penetrate cell walls.

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Alternative method for voriconazole impurity E
ion chromatography

Alternative method for determination of voriconazole impurity E

Voriconazole is an antifungal medication that is included on the WHO Model list of Essential Medicines. During synthesis of the active ingredient a resolving agent for chiral amines is often used, and it is thus necessary that the quality control prove that this substance is not present at harmful levels in the final product.

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Pharamaceutical counterions with XAMS suppressor and ASUREX-A200
ion chromatography

Generic method for isocratic separation of ten common pharmaceutical counterions

Many medicines and dietary supplements are bases that carry a positive charge, and these small molecules are consequently accompanied by negatively charged counterions. Such anionic excipients may influence the properties of the pharmaceutical formulation and can also influence the effect of the active ingredient since different ion pairs can have different dissolution rates or abilities to penetrate cell walls.

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I’ll be happy to answer any questions you might have regarding our products and services.

Tobias Jonsson
CEO, PhD in chemistry
Mobile: +46 705783490
E-mail: tobias@diduco.com

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