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:
Software that enables dissolution tests:
The data shown illustrates the analysis of the components of a common oral contraceptive containing ethinyl estradiol and norethindrone, in one fully automated HPLC run, using both fluorescence and UV detection.
Fluorescence detection for ethinyl estradiol
UV detection for norethindrone
The Empower Software dissolution run setup wizard is shown along with its flexible reporting capabilities. The software automatically monitors bath conditions, for complete compliance.
Empower Software’s Dissolution Option screenshots