Industry: pharmaceutical

Strict quality control of medicines is a cornerstone of modern healthcare all around the world. Much of these analyses are performed by determining identity and concentrations of active ingredients, impurities, raw materials, counterions and other excipients in pharmaceutical formulations.

Diduco contributes by providing reliable products and developing new methods following the ICH guidelines, thus complying with the requirements in pharmacopoeia monographs including USP and Ph. Eur., that are enforced by FDA and other regulative bodies. Diduco support initiatives to develop modernised and more appropriate monograph methods using modern tools and instruments and have for example developed and published a new validated assay for the antiviral medicine foscarnet using suppressed ion chromatography.

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 analytical quality by design (AQbD) 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 chromatography

Preserving eluent quality with dedicated storage protected from ambient carbon dioxide

To ensure that liquid chromatography analysis methods meet regulatory demands of retention repeatability as dictated by pharmacopoeia and the ICH guidelines, it is important to protect weakly buffered eluents from ambient carbon dioxide. The formation of carbonate species will otherwise change the pH and strength of the eluent, thus shifting retention.

ion chromatography

Analysis of dietary supplement capsules with carnitine using a generic method for counterions

Oral L-carnitine is a dietary supplement that has been shown to reduce fatigue in elderly people with low muscular endurance, but its effects on athletes during physical activity are not well-supported. Although this endogenous compound is well-known for its involvement in the mitochondrial oxidation of long-chain fatty acids, no scientific evidence has been found that carnitine in isolation enhances fat-burning.

ion chromatography

Determination of sulfamate and sulfate in topiramate tablets according to USP monograph

Official quality control method for the second-generation antiepileptic drug topiramate which also have shown effect against migranes. This analysis was performed according to the United States Pharmacopeia monograph and determines the degradation products sulfamate and sulfate which can be formed during storage in humid environments or at elevated temperatures.

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.

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.

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.

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).

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.

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 consequently these small molecules are 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.

ion chromatography

Analysis of dietary supplement capsules with glucosamine using a generic method for counterions

Oral glucosamine is a dietary supplement that is marketed to support the structure and function of joints and claimed to provide pain relief for people with arthritis and osteoarthritis, although there is no clear evidence that its benefit is significantly above placebo.

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.

ion chromatography

Generic method for isocratic separation of ten common pharmaceutical counterions

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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