In addition to extensive extractables and leachables testing services, we offer other analytical services using our organic and inorganic analysis tools. We pride ourselves in being able to meet unique customer requests and solve challenging analytical problems.
Elemental impurities have always been a key issue for pharmaceuticals, but with FDA’s Jan. 1, 2018 implementation of USP General Chapter <232> testing is now mandated for all new and existing drugs.
VR Analytical leverages its years of experience assessing risk, expertise in materials assessment, and a benchmark ICP-MS method to identify known and potential sources of elemental impurities that may find their way into a drug product (learn more).
Our team of analytical scientists is capable of developing methods to detect trace organic contaminants in a variety of sample matrices, as well as assay for potency and purity of active ingredients or excipients. With our array of analytical instruments we can detect volatile and semi-volatile compounds using gas chromatography with liquid and headspace sampling, and detection with mass spectrometry and flame ionization detection (learn more).
Standard LC-MS techniques are often unable to identify unknown compounds because the measured values (e.g., 409.1 m/z) are not sufficient to determine molecular formulas. High resolution accurate mass measurements (e.g., 409.1625 m/z) combined with isotope ratio data can be used to determine the molecular formula of an unknown compound (learn more).
VR Analytical has a multidisciplinary team that can solve your analytical challenges. Among the consulting services we provide are NMR interpretation, isolation of active ingredients and trace contaminants or impurities, TFF cassette optimization, mass spectral interpretation, and processing material selection (learn more).