AGILENT

21st September

10:00 – 12:00

Labforum Workshop Room

Advanced tools for the analysis of Extractables and Leachables

Speakers:

Antonio Chana, LC Product Specialist at Agilent

Fernando Tobalina, Spectroscopy Product Specialist at Agilent

Jaume C. Morales, LCMS Product Specialist at Agilent

Jose Juan Rivero, GC/GCMS Product Specialist at Agilent

Summary:

Compounds with the ability to migrate from packaging or production systems can cause chemical contamination in pharmaceutical substances and products. As a quality management strategy, it is necessary to identify these compounds and ensure that drugs meet expected quality standards. Typically, these compounds are present in low concentrations and are masked by the drug matrix. Therefore, highly sensitive and selective methods are required to detect and identify these compounds.

The complexity of potential Extractables and Leachables (E&L) is high, as they contain chemicals with a wide range of classes and concentrations, as well as pose challenges for the identification of these compounds. Various technologies are required to avoid omitting contaminants that pose a potential threat.

In this workshop, we will present Agilent’s solutions to meet this challenge not only from a research perspective, but also as routine tools to implement in quality control with strict compliance checks through computer systems specifically designed to meet the most stringent controls.

Different technologies based on mass spectrometry, for the detection and identification of both organic and inorganic species, suitable for detecting and identifying extractables and leachables (E&L) impurities of pharmaceutical products will be shown.

Agilent’s tools for statistical data analysis, specific to determine compounds present in samples compared to controls, as well as database search tools to identify E&L using both an IE and accurate mass database will also be demonstrated.

For the identification of unknown E&L, several alternatives are presented such as using LC MS/MS data in conjunction with structure prediction software or using a high resolution accurate mass GC/Q-TOF equipped with a low energy IE capable ion source.