Get your resource kit for extractables and leachables testing in pharmaceutical industry

Drug containers and modern drug delivery systems are meant to protect a drug from environmental contamination but they are actually themselves a source of contamination.

Waters provides comprehensive support to the pharmaceutical industry to ensure the safety considerations of your material are met. Find out how we can help you have more accurate, rapid and reproducible results on your identification of extractable, leachable and NIAS contaminants.

The examination of Extractable and Leachable substances is extremely important for the protection of your patients and for regulatory documentation destined for authorities such as the FDA and EMA. As stated in the U.S. FDA 21 CFR 211.94(a) statement: "Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug beyond the official or established requirements".

Waters provides a wide range of technologies including liquid chromatography, Atmospheric Pressure GC, convergence chromatography, mass spectrometry, supercritical fluid extraction, consumables, standards and high quality scientific library, that enable accurate, rapid and cost effective identification and quantification of extractable, leachable and NIAS contaminants.

Fill in the form below to access your essential Pharmaceutical E&L resource kit to learn more.

The resource kit includes:

• On demand Webinar: Learn about how 3D printed materials were analyzed for organic, metal, and particulate matter impurities using high resolution MS data to identify unknown analytes. Hosted by C&EN.
• Application Note: This application note describes the utility of Waters™ ACQUITY Arc System coupled with PDA and the ACQUITY QDa Mass Detector for the analysis of betamethasone valerate (BMV) scalp application for impurities, according to USP-NF 35 monograph methods.
• Application Note: In this application note, four different types of packaging material were extracted and screened for 14 common polymer additives. The UPC² analysis was compared to GC and UPLC chromatographic profiles. The UPC² analysis provided a two-fold improvement in run time compared to UPLC, and an eight-fold improvement in run time compared to GC.
• Application Note: This application note focuses on the analysis of extractables in the pharmaceutical and food packaging industries. The ACQUITY UPC² System streamlines the analytical workflow by providing flexibility with various common solvent systems. The MV-10 ASFE System represents a substantial savings in solvent consumption and run time as well as greater flexibility than other extraction techniques.
• Application Note: This technical note describes a simple workflow and methodology for the screening and characterization of 3D printing media, and pharmaceutical packaging extractable applications.
• Infographic: Simplifying the screening workflow of extractables
• White paper: This white paper highlights five different compound types commonly used in consumer products—biocides, disperse dyes, flame retardants, phthalates, and primary aromatic amines—and some of the analytical and regulatory challenges related to each. For each type of compound, a related application describes the use of novel liquid chromatography and mass spectrometry technologies to solve complex analyses.