Novel Instrument Solution for Content Uniformity Sample Preparation

Jeff Seely, Sales, Distek, Inc., North Brunswick, USA (jeff.seely@distekinc.com)

The Uniformity of Dosage Units by Content Uniformity test covered in USP chapter <905> is required for most dosage forms. Unlike dissolution, disintegration or physical parameters testing, the actual details of how to perform content uniformity testing are largely unspecified, and thus, unlike the other tests, have not lead a preponderance of dedicated instruments. The solutions that have been offered have attempted to automate the entire test, including sample extraction/prep and analysis. As a result, these solutions have been very complicated and expensive. This talk will present an innovative instrument that addresses only the sample prep portion of this test. Limiting the scope of the functionality of this instrument greatly reduces its complexity and cost. This unit reduces the multiple steps and tools conventionally used for content uniformity sample prep to a single ultra-efficient process, reducing the sample prep time by as much as 90%. The disposable sample tubes used in this design further eliminate errors due to sources such as cross-contamination and incomplete sample incorporation, preventing mistakes which necessitate tedious Stage 2 testing. Examples of suitability and sample preparation times reduction in actual pharmaceutical products will be demonstrated. Data showing comparable content uniformity results from this instrument versus existing sample prep methods will also be presented.