In this article, from Issue 12 of the Analytix Reporter, produced by Merck, an LC-UV/MS method is presented using a corresponding E&L certified reference material (CRM) mix for the LC determination of extractables and leachables.

E&L_AR12

Extractable & leachable (E&L) analysis of single-use equipment is a crucial assessment to ensure product safety and quality. This article reports on the efficient identification and quantification of unknown extractables of a single-use system using a certified reference material (CRM) mix for extractables and leachables. 

Single-use systems (SUS) made of polymers are commonly used components in the manufacturing or handling of drugs. This direct contact can lead to the contamination of the drug by leaching of the polymeric material components into the product.

To manage this risk, it is crucial to understand the compounds that might potentially migrate from a material (extractable study) and also the quantities at which such a migration is occurring under certain conditions (leachable study).

As described in the BPOG (BioPhorum Operations Group) guidelines and USP <665> guidelines for polymeric components and systems (draft version), investigations regarding extractables should be performed using various solvents and incubation times with the analysis done using a variety of analytical methods applied to the extracts.

A well-suited method to analyze non-volatile extractables such as additives, impurities, polymer components, or degradation products is liquid chromatography-ultraviolet spectroscopy/mass spectrometry (LC-UV/MS). UV and MS are chosen to detect a wide range of extractables. As generally the exact composition of the polymeric material is unknown, a non-targeted analysis is required that involves the detection and identification of any potential extractable.

To facilitate this type of analysis, the company has developed a CRM mixture for 21 extractables typically found in LC-UV/MS studies. This CRM mix is not only helpful for a quick identification of unknown extractables but can also be used for quantification with traceability to a NIST SRM.

The article reveals how all 21 reference compounds were detected by the combination of a UV-MS detector with almost complete separation and further demonstrates the applicability and value of the Extractables and Leachables Screening Standard in LC analysis.

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*The life science business of Merck operates as MilliporeSigma in the U.S. and Canada.

Published  Jun 23, 2022

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