Dissolving pharmaceuticals

Thermo Electron has concluded an OEM Agreement with Sotax AG, whereby Sotax dissolution baths will be offered with Thermo's Nicolet Evolution 300 UV/vis spectrophotometer. This collaboration will provide pharmaceutical customers with a high-quality, complete, and automated turnkey system supporting various pharmacopoeia methods.

Sotax is the exclusive provider of the Hollow-Shaft sampling technology and the Autocompliance concept with its dissolution baths, which simplifies bath validation, and pioneers in flow-through dissolution and automated testing solutions. These dissolution and tablet testing tools meet and exceed USP and FIP guidelines. WinSotax advanced dissolution software offers the tools necessary to achieve 21 CFR 11 compliance.

Thermo's Nicolet Evolution 200 UV/vis spectrophotometer is claimed to be the first UV/vis product on the market that use the Smart Accessory sampling concept, thereby providing automatic accessory and serial number recognition, initialisation and logging. Enhanced and automated validation qualification performed with NIST or NPL traceable standards and primary standard mercury emission lines are also an integral part of this system.

The combined system will include control of up to two dissolution baths with a single UV/vis instrument, validation and software tools allowing customers to achieve 21 CFR Part 11 compliance. It will also offer a more convenient and tailor-made solution incorporating qualification and validation tools in order to streamline processes.