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

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)...

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...

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:...