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Active substance release analyses

One defining feature of a pharmaceutical product is the dissolution location and duration of its active substance. Hence, this dissolution has to be defined during development, and constantly monitored afterwards. Pharmacopoeias provide clear guidelines on monitoring methods and specifications for a wide variety of dosage forms including tablets, capsules, transdermal systems and ointments.

Our state-of-the-art laboratory owns dissolution test equipment with both baskets and paddle mixers. This enables us to analyse a variety of immediate, extended-release or delayed-release dosage forms. Sampling can be carried out manually or by autosampler.

Besides monitoring at any predetermined time-point we can provide dissolution profiles by repeated sampling over a given timespan, e.g. for bioequivalence studies. Those profiles can be short-term or long-term. The subsequent quantitative analysis can be performed using UV spectroscopy, HPLC analysis or titration. Analysing highly active substances like cytostatics is also available.

We at BioChem support You by developing and validating new dissolution techniques,  creating  dissolution profiles, and performing dissolution monitoring for product release and stability testing. This is all performed in compliance with the GMP guidelines.

Our highly experienced team has a profound knowledge and long-term experience from numerous dissolution monitoring projects. Thus guaranteeing smooth processes in both development and routine, even with high sample counts. We offer competent support, and process your samples quickly, purposefully and in compliance with all quality specifications, no matter how many there are. We find a solution für all your problems.

By the way, we also offer a broad variety of testing methods for solid dosage forms, including friability testing, disintegration testing and more. We are glad to hear from you!

Contact the experts of our analytical department

Contact

The experts in our analytical department will be pleased to provide you with advice and support in planning and carrying out analytical tests for your products or projects. We will be pleased to prepare an offer tailored to your current issues.

Please use our contact form for your enquiry.