99310071-Rev.-01-21-XTRX500-Sample-Preparation-Extractor

Product catalog summary

Overview: The XTRX500 Sample Preparation Extractor by Teledyne Hanson is designed for rapid and efficient extraction of active pharmaceutical ingredients (API) for content uniformity testing. It combines high-frequency pulverization and forced-jet mixing in a compact, programmable system.

Specifications: The system uses chemically compatible, single-use recyclable pouches to eliminate issues related to glassware handling and manual sample preparation errors. It supports various dosage forms including tablets, capsules, powders, and more.

Procedure: The extraction process involves clipping an extraction pouch into the XTRX500 cassette, adding solvents, and placing the dosage form into the pouch. The system can operate in immediate mode or use stored methods, with up to 30 events per method.

System Components: Key components include a powerful crushing mechanism, reciprocating rollers for mixing, single-use pouches, and a programmable control panel. The system is designed for ease of use and minimal operator training.

Control Panel: Features a user-friendly interface with a single-knob control, self-test mode, and USB data port for firmware updates. It allows method creation, editing, and storage with password protection.

Ordering Information: The XTRX500 is available in various configurations with different pouch sizes. Accessories and consumables such as spare cassettes, pouch compression tools, and syringes are also available.

Extraction Pouch Technology: Pouches are designed for optimal extraction conditions, with a crushing zone and solvent section. They come in 100 mL and 500 mL sizes, suitable for different fluid volumes.

Performance Examples: The XTRX500 significantly reduces extraction times across various applications, such as reducing heterocyclic extraction from 16 hours to 1 minute and NSAID extraction from 12 hours to 2 minutes.

Contact Information: For further details, contact Teledyne Hanson at [email protected] or visit their website.

Catalog excerpts

99310071-Rev.-01-21-XTRX500-Sample-Preparation-Extractor-1

Sample Preparation Extractor (XTRX500) Lightning Fast Extraction of API for Content Uniformity Testing

Open the catalog to page 1

99310071-Rev.-01-21-XTRX500-Sample-Preparation-Extractor-2

XTRX500 SAMPLE PREPARATION SYSTEM SAMPLE PREPARATION FOR CONTENT UNIFORMITY Accurate and repeatable sample preparation is essential to determining content uniformity in pharmaceutical products. “To ensure the consistency of dosage units, each unit in a batch should have a drug substance content within a narrow range around the label claim.” USP <905> Uniformity of Dosage Units. Traditional methods of sample extraction are often tedious and time-consuming, especially with problematic drug formulations that may take many hours to dissolve. Teledyne Hanson’s new Sample Preparation Extractor (XTRX500)...

Open the catalog to page 2

99310071-Rev.-01-21-XTRX500-Sample-Preparation-Extractor-3

XTRX500 SYSTEM COMPONENTS The rapid and reproducible extraction process of the XTRX500 is made possible by its powerful crushing mechanism combined with forced-jet mixing, singleuse pouches, and a programmable interface. Powerful crushing. High frequency pulsing in the crushing mechanism rapidly reduces whole solids to fine powders, greatly accelerating the release of API from the dosage form. Rapid mixing. Reciprocating rollers on the mixing bar generate high turnover of fluids inside the pouch for faster dissolution and a homogeneous mixture. Single-use pouches. Containing the process within...

Open the catalog to page 3

99310071-Rev.-01-21-XTRX500-Sample-Preparation-Extractor-4

XTRX500 SAMPLE PREPARATION SYSTEM XTRX500 EXTRACTION POUCH TECHNOLOGY The XTRX500 extraction pouch is custom designed to provide the optimum conditions for rapid sample extraction. The crushing zone in the top section accepts the dosage form in its original shape with no need to break it down in advance. The lower section contains the solvent and the final sample solution. Fluid pathways between the two sections allow forced jet mixing—produced by four reciprocating rollers operating against the lower section—to accelerate dissolution. Pouches made from durable polypropylene come in two sizes:...

Open the catalog to page 4