active ingredients

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).

ion-exclusion chromatography

Separation of organic acids by ion-exclusion chromatography

Separation of organic acids can be a challenging task due to their hydrophilic nature and structural diversity. One of the more traditional approaches to this analysis is ion exclusion chromatography, which offer complementary selectivity to other separation techniques, especially for the monovalent acids which tend to be more strongly retained in this mode.

Cannabinoids in hemp using Raptor ARC-18

reversed-phase

Analysis of cannabinoids in dried industrial hemp after methanol extraction

The legislation in many countries allow cultivation of industrial hemp provided that the strains do not produce high amounts of tetrahydrocannabinol (THC) and other psychoactive cannabinoids classified as narcotic substances. These strains of cannabis sativa are instead typically rich in compounds such as cannabidiol (CBD) and cannabidiolic acid (CBDA).

Foscarnet assay calibration with XAMS suppressor and ASUREX-A200

ion chromatography

Modernized assay for foscarnet following ICH guidelines

New preliminary 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 method 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.

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.

Keyword: active ingredients

Applications

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

Separation of organic acids by ion-exclusion chromatography

Analysis of cannabinoids in dried industrial hemp after methanol extraction

Modernized assay for foscarnet following ICH guidelines

Analysis of clodronate related substances according to European Pharmacopoeia monograph

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