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To ensure drug product efficacy, components of primary packaging and delivery systems must be evaluated for safety and performance. An essential aspect of this is an extractables and leachables (E&L) study. The purpose of an E&L study is to identify compounds (organic and inorganic) that may migrate from components into drug product formulations, in particular those that may put patient safety at risk.
The first phase is the extractables evaluation. This employs aggressive conditions to extract and ultimately identify any compound that possibly could appear in the drug product formulation. Components are refluxed in a selected liquid media at elevated temperature for a fixed time. Resultant media typically is analyzed via chromatography and mass spectrometry, for both presence and identity of compounds. Accuracy of standard mass spectrometry techniques often is not sufficient though.
Some compounds are difficult to identify by a molecular weight value reported by unit resolution mass spectrometers. To address this issue and most accurately identify extracted compounds, West Analytical Laboratory Services has acquired quadrupole time of flight (QTOF) mass spectrometry instrumentation. Providing molecular weight values to four decimal places, QTOF instrumentation enables increased accuracy in identifying extracted compounds. This information is crucial; knowing identities enables evaluation of potential toxicity, and concomitant determination of whether said compounds should be targets of the subsequent leachables study.
Many properties of packaging components/systems and delivery devices can be measured by multiple methods. The key is to select the right methods. West’s Analytical Lab Services is well equipped for this, having the staff, expertise, and facilities needed. For more, contact an Account Manager or Technical Customer Support (TCS) representative.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.