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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) provides an advanced, efficient solution for rapid extraction through an innovative, proprietary combination of high frequency pulverization and forced jet mixing in a compact, programmable platform.

As samples are prepared within chemically compatible, single-use recyclable pouches, XTRX500 eliminates many of the problems associated with handling glassware, manual crushing, dry material measurement and transfer, cleaning validation, and the reproducibility errors inherent in manual sample-prep methods.

XTRX500 rapid extraction process

The sample extraction process using XTRX500 is fast and easy. The analyst clips an extraction pouch into the XTRX500 cassette, adds a mixture of solvents consistent with API dissolution, and places the dosage form into the top of the pouch.

Applicable dosage forms for single-sample or bulk-assay mode include tablets, lozenges, capsules, powders, beads, granules, gels, pastes, pastilles, and wax suppositories.

The analyst mounts the cassette onto the XTRX500 body and from the control panel selects from the methods stored in the system, or chooses “immediate mode” to set parameters for an unstored method. High-speed pulverizing then occurs within the crushing zone for the programmed amount of time. Forced-jet mixing runs simultaneously from the start or begins later, as specified by the method.

When crushing and mixing are complete with the sample fully dissolved, the analyst uses a syringe to extract the aliquot(s) required by the analytical method and places them into appropriate vials for transfer. The pouch is removed from the cassette, emptied, and recycled or disposed of according to the lab’s standard operating procedures.

XTRX500 Sample Preparation Extractor Demonstrated

Programmable control panel

The user-friendly XTRX500 interface with its single-knob control makes it fast and easy to create and run extractions. The system can be run either without a pre-programmed method (walk-up immediate mode) or with up to 30 events per stored method.

The system’s self-test mode checks all sensors on start-up. Incorrect pouch installation and method programming errors are automatically detected and prevented. New method development is facilitated by unlimited use of Pause, Stop, and Resume functions.

Setting a system password protects stored methods. Easily install firmware updates via the USB data port.

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: a 100 mL pouch for fluid volumes of 25 mL to 100 mL, and a 500 mL pouch for volumes of 100 mL to 500 mL.

XTRX500 accelerated extraction examples

The XTRX500 method saves time and materials while reducing variability in a wide range of applications.

  • Extraction of heterocyclic from prolonged-release hydrogel matrix reduced from 16 hours to 1 minute.
  • NSAIDS from wax suppository reduced from 12 hours to 2 minutes with no need to boil and with reduced solvent consumption.
  • Water-soluble vitamin from prolonged-release cellulose reduced from 18 hours to 3 minutes.
  • Hard lozenge extraction reduced from 12 hours to 2 minutes and with no loss of sample.
  • Heterocyclic alkaloid extracted from tobacco reduced from 4 hours to 1 minute.
Teledyne HansonTeledyne Hanson is a global technology company that specializes in analytical test instruments for the pharmaceutical industry. Founded in 1951 by Dr. William A. Hanson, innovator of modern dissolution and diffusion test technology, Teledyne Hanson helps ensure the world’s pharmaceuticals are pure, safe, and effective by manufacturing equipment that sets the global standard for quality, innovation, and long-term value. Teledyne Hanson instruments are used by scientists in over 75 countries worldwide and are supported by the industry’s top customer service team.
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