Dissolution testing.
For the precise determination of the release of active ingredients in solid dosage forms and narcotics (BTM).
Do you want to ensure that your release studies deliver controlled, reproducible, and GMP-compliant results? Reliable dissolution testing is crucial for evaluating the bioavailability of drug forms and meeting regulatory requirements. Only when the drug release is precisely characterized can regulatory authorities confirm the quality and efficacy of your product.
We perform dissolution tests in accordance with applicable pharmacopoeias and tailor the test conditions precisely to your formulation. This ensures that your drug form exhibits the desired properties even under realistic conditions. Our tests cover both standard tablets and complex retard formulations.
Our technologies at a glance:
- UV detection – for fast and precise determination of active ingredient release.
- HPLC detection – for detailed analyses, quantification, and creation of release profiles (including f₂ comparison).
- BTM analyses – many years of experience in testing the release of narcotics under the strictest regulatory requirements.
In addition, we offer method development, validation (IQ/OQ/PQ), and automated dissolution analyses upon request. These options enable maximum efficiency, complete documentation security, and seamless regulatory compliance.
Our customers benefit not only from state-of-the-art analytics, but also from reliable advice on strategy, study design, and regulatory issues. We support you from the early development phase through to submission to authorities such as the EMA or FDA.
Your advantage: With CUP Contract Labs, you can be sure of accurate, GMP-compliant, and audit-proof release studies—for fast approval and maximum product safety.
