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. We support initiatives to develop modernised and more appropriate monograph methods using modern tools and instruments and have for example developed a new assay for the antiviral medicine foscarnet using suppressed ion chromatography.

Applications

Tartrate in dietary supplements

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.

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Foscarnet assay calibration with XAMS suppressor and ASUREX-A200

Modernized assay for foscarnet following ICH guidelines

New assay for the antiviral medication forscarnet 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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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

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

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

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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Talk to us

Get in contact
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

Diduco is a leading provider of professional services in high performance liquid chromotography and producer of the Xenoic® XAMS chemical suppressor and ASUREX automatic regenerator for ion chromatography.

Diduco AB
Tvistevägen 48C
90736 Umeå
Sweden

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