Dissolution Analysis measures a drug's rate of release from its dosage form. Dissolution Analysis is routinely performed to provided critical drug release information for drug development and quality control purposes. It is also used in stability studies to determine effects of time, temperature, and humidity on a drug sample, as well as in comparator studies.
Boston Analytical has been performing extensive dissolution testing since 1987. Our deep understanding of USP method <711> coupled with our sophisticated dissolution apparatuses I, II, III, IV, V, and VII enable us to deliver strong and reliable results for human bioequivalence studies as stated by the Food and Drug Administration (FDA). Boston Analytical's commitment to working with only the most up-to-date apparatuses and information technology systems ensure your results are delivered with confidence and on-time. Our well-equipped laboratory offers comprehensive testing services according to the pharmacopoeia (e.g. USP) and to your specifications.
Dissolution Apparatus Services Offered
- USP Dissolution Apparatus I – Basket
- USP Dissolution Apparatus II – Paddle
- USP Dissolution Apparatus III – Reciprocating Cylinder
- USP Dissolution Apparatus IV – Flow-Through Cell
- USP Dissolution Apparatus V – Paddle over Disk
- USP Dissolution Apparatus VII - Reciprocating Holder Apparatus
Method Development & Validation of Dissolution Methods
Developing the techniques and the steps of an analysis, or verifying your current methods can also be performed here at Boston Analytical. Our Method Development projects can be custom-designed to meet your specific analytical requirements, or you can choose to use the methods developed according to Boston Analytical's proven methods. All of our methods are validated in compliance with USP and ICH guidelines, using client protocol, or customized Boston Analytical protocols.
Our methods are user-friendly; we provide you with a written method development and validation report with every method. Our methods are written in an easy-to-understand, step-by-step format to simplify method transfer.
For more information on our Dissolution Analysis Services, please contact Boston Analytical today.