CD14 Vessel to Vessel Temperature Stability
over Extended Time Periods Application Note Request

Summary
The Teledyne LABS 14-vessel CD14 Comparative Dissolution Tester runs two methods simultaneously or independently, making it an ideal apparatus to evaluate bioequivalence for abbreviated new drug applications (ANDA) for generic drugs. The 14 stirring positions allow for 6+1 or 12+2 configurations for improved workload efficiency in R&D, formulation development, quality control, and for stability test labs. With digital temperature probes at 12 positions, the CD14 can test two different formulations with separate settings for every parameter under the same environment. The CD14 is controlled by a fast, powerful computer built into the color touchscreen display mounted to the drive head. The adjustable tilt angle accommodates operators of different heights, while the Linux-based operating system with its own SQL database responds instantly to user input. The highly durable
resistive touch screen works with or without the protective Ashvin Patel, PhD. gloves generally used by chemists in a laboratory setting. The CD14 has an easy-to-use interface that includes context-sensitive help. It logs events, errors, test reports, test history, service, and any changes made by users. The new methods or test parameters
can be programmed quickly.

The CD14 Tester is very useful for performing a comparative dissolution test for oral solid products like tablets, capsules, etc. These products exist in a variety of release characteristics such as immediate-release, sustained-release, delayed-release, extended-release, etc. A comparative dissolution test in various dissolution medium
must be performed during product development, ANDA submission, and after approval for Scale-Up and Post-Approval Changes (SUPAC). The Federal Drug Administration (UD-FDA) has published multiple guidance documents regarding the dissolution test and its requirements, including much product-specific guidance.

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