Dissolution testing is essential in the formulation, development, and production process for quality control and release in drug manufacturing.
The dissolution profile is used to demonstrate reliability and batch-to-batch uniformity of the active ingredient. Often this is a bottleneck in the overall evaluation process since many laboratories still rely on manual sampling at specified time points to construct this profile. Additionally, newer and more potent formulations require increased analytical sensitivity.
Testing higher potency drugs is particularly important in sustained-release dosage formulations where dissolution can often be the rate-limiting step in medicine delivery.
Waters provides precise and reliable automated online sample acquisition with the unmatched performance of Alliance® HPLC or ACQUITY UPLC® instrumentation. Our LC systems automate dissolution testing, from pill drop to test start, through data acquisition and analysis of sample aliquots, to the management of test result publication and distribution.
Chromatographic solutions for dissolution testing:
- Waters Dissolution Solution with UPLC: Collect samples for post-run analysis utilizing UPLC, ideal for today’s low-level high potency multi-component medicines
Software that enables dissolution tests:
- Empower™ Software with Dissolution option, also integrates with software partner testing stations
- Use a simple wizard-driven interface to customize dissolution method setup, data collection, processing and reporting of results
- Control all system components with a compliant-ready solution for the laboratory
- Fast methods development for all components without the need for standard runs
