Teledyne XTRX500 User Manual page 9

46-208-208 Rev. B—XTRX500 User Guide
An apparatus and consumable for rapid extraction of solid and
semi-solid dosage forms.
NOTE: The XTRX500 is designed to be a tool that will allow the
analyst to extract and dissolve solid and semi-solid dosage
forms. The actual extraction success is highly dependent on the
analyst's ability to develop a method within the constraints of
the XTRX500 tool.
The dosage forms include the following, but it should be noted
that they are limited to the constraints of the XTRX500
extraction pouch dimensions and design:
Tablets (immediate and controlled release)
•
Lozenge
•
Capsules (both gelatin and alternatives)
•
Powders
•
Beads & granules
•
Gels and pastes
•
Pastilles
•
Wax suppository
•
Large tablets (up to 40 mm width) and small tablets
•
(3 mm width)
NOTE: The system is not to be used with effervescent tablets
or mixtures that produce a gas when mixed together.
The system (includes instrument [electromechanical device with
firmware & software] plus consumable) provides automated
rapid extraction of dosage forms.
The operator is responsible for fluid addition, filtration and
dilution steps related to their method, the system gives the user
easy access with the ability to add the sample and add and
remove fluid at appropriate stages of the method.
The extraction pouch contains all the extraction fluid and no
solution should come into contact with the hardware or reusable
components, eliminating cleaning between samples.
The XTRX500 is a standalone system appropriate for
laboratories and manufacturing units allowing easy and
controlled extraction of the product(s).
A. Introduction
A-4