EKG Labs is now the proud owner of an Agilent Ultra High Performance Liquid Chromatograph (UHPLC) with Quadrupole Time of Flight Mass Spectrometry Detection (q-ToF MS). This instrument is a cutting-edge tool for profiling, identifying, characterizing, and quantifying non-volatile and semi-volatile compounds and biomolecules even in challenging matrices. While EKG already has multiple UHPLC and HPLC systems, a Time-of-Flight Mass Spectrometer, and Ion Trap Mass Spectrometer, this new instrument provides expanded 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, nitrosamine analysis, and other customized analytical services.
Agilent 1290 Infinity II UHPLC
- Additional chromatographic resolution
- Higher peak capacity for challenging separations
- Lower detection limits
- Higher retention time precision
- Expanded injection volume range
Agilent 6546 q-ToF
- Mass accuracy <0.8 ppm for very accurate mass calculations to leverage isotopic information
- Mass resolution >30,000 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
- Electrospray ionization (ESI) and Atmospheric-pressure chemical ionization (APCI)
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 over 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
EKG Labs is an analytical service provider for the pharmaceutical and medical device industries. Our wide variety of analytical services support product development, regulatory filings, and analytical chemistry investigations. EKG Labs is now a part of the Infinity Laboratories group, a powerful network of state-of-the-art testing facilities that are FDA registered, ISO 17025 accredited, and DEA licensed. With an enhanced focus in the areas of chemical and microbiological sciences, we support pharmaceutical and medical device manufacturers. Our goal is to go Beyond Testing and become a partner in the success of our customers.
Some of our services include:
To find out more about our analytical offerings, please contact us at info@ekglabs.com or at 810-354-5229.
