As of March 2018, EKG Labs is now the proud owner of an Agilent Ultra High Performance Liquid Chromatograph (UHPLC) with Accurate-Mass Time of Flight Mass Spectrometry Detection (ToF MS). This instrument is a cutting-edge tool for profiling, identifying, characterizing, and quantifying low molecular-weight compounds and biomolecules even in challenging matrices. While EKG already has multiple HPLC systems, including an impurity probing Ion Trap Mass Spec, this new instrument provides additional analytical capabilities. Though primarily intended for our comprehensive extractables and leachables (E&L) studies, this new instrumentation will also support programs such as impurity identifications, characterization of degradation products in stability studies, reference standard characterization, and other customized analytical services.
Some specific advantages of this new system include:
- Additional chromatographic resolution
- Higher peak capacity for challenging separations
- Lower detection limits
- Higher retention time precision
- Mass accuracy <1 ppm for very accurate mass calculations to leverage isotopic information
- Mass resolution >22,000 to distinguish target analytes from matrix interferences
- Mass range up to mass-to-charge ratios (m/z) of 20,000 for high molecular weight polymers, etc.
- Picogram (10-12g) on-column sensitivity for trace-level target compounds
- 5 orders (wide) of in-spectrum dynamic range, perfect for the detection of low concentration impurities among highly abundant compounds
In addition to the instrument itself, EKG Labs has acquired the latest edition of the MassHunter Workstation software with an integrated extensive extractables and leachables library. The MassHunter software will be used by EKG Labs for compound-centric data mining and generation of molecular formulas, notably adding algorithms for the extraction of molecular features and extensive database or library searches. The Extractables and Leachables Personal Compound Database and Library (PCDL) features spectra for 1000 targeted extractable or leachable compounds, along with MS/MS data for 360 compounds. These compounds include everything from plasticizers to inks to residual monomers and beyond.
Adding this instrument and its accompanying software to EKG’s extensive expertise in this area will serve the growing needs of EKG Labs’ ever-expanding clientele in the pharmaceutical and medical device industries.
About EKG Labs
Understanding the complex chemical interactions between materials and their surrounding matrix/ environment is critical to designing a proper extractables and leachables program. The head of our analytical team, Dr. Allen Kesselring, is known throughout the pharmaceutical and medical device development industries for designing and managing complex E&L programs. EKG Labs is familiar with guidance from organizations such as USP, ICH, ISO, and BPOG. Our full scale GMP analytical capabilities include:
- Extractables and Leachables Studies
- Method Development
- Method Validation
- Chemical Characterization
- Impurity Identification
EKG Labs is an analytical service provider for the medical device and pharmaceutical industries. Our analytical services support regulatory filings, product development, and analytical chemistry investigations.
To find out more about our E&L programs and other analytical services, please contact us at 810-354-5229.