MORE OPTIONS FOR TESTING PHARMACEUTICAL PRODUCTS New Dissolution Testing System Boosts Productivity

The basic system for off-line dissolution testing comprises an HP 8453 spectrophotometer, an HP ChemStation, and software.

The process of sampling, analysis, calculation, and reporting of results is generally recognized as the most labor-intensive and time-consuming part of a dissolution test. A new dissolution testing system from HP fully integrates multivendor equipment to provide scaleable solutions that improve productivity by saving time.

The system is based on the HP 8453 UV-visible spectrophotometer and the HP ChemStation for UV-visible spectroscopy. A basic system for off-line testing comprises an HP 8453 spectrophotometer, an HP ChemStation, and software. Sampling is done manually, by a sipper, or by an autosampler.

Versatile Operation

For on-line testing with automatic sampling from the bath, users can choose multicell or valve operation. Valve operation provides scaleable solutions with one, two, three, or four dissolution baths for increased productivity -- with the option to run different methods on different pharmaceutical products for each bath.

Meets Pharmacopeia Requirements

The HP 8453 spectrophotometer forms the analytical centerpiece of the dissolution testing system. With a wavelength range of 190-1100 nm, a 1-nanometer slitwidth and less than 0.05% stray light, the HP 8453 meets all requirements of both the European and the United States Pharmacopeias.

The HP 8453 dissolution testing system can be used as effectively with conventional types of dissolution test apparatus (USP Types 1 and 2), as with less common systems, such as flow-through and other apparatus (USP Types 3 and 4.)

Advanced Compliance Features

The software for the new dissolution testing system is an add-on module for the HP ChemStation general-purpose UV-visible software. Running within the Microsoft® Windows® 95 and NT environments, the dissolution testing software uses the same easy-to-use graphical user interface (GUI) as HP's highly acclaimed general-purpose, advanced and biochemical analysis UV-visible software. Once familiar with the GUI, operators can move comfortably between the different modules. The dissolution testing software builds on the GLP features of the general-purpose UV-visible software, providing advanced compliance capabilities.

Other features of the dissolution testing software include flexible pre- and postrun sequences -- for example, for remeasuring standards or control samples, or for report generation -- and automatic correction for volume changes caused by pH change, sampling, or evaporation.

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