Sunday, July 14, 2024



Pharmaceuticals: Actives, Formulations, Degradants

New scientific discoveries and regulatory safety requests drive the need for comprehensive, highly sensitive, and accurate analytical approaches. Often the key question to be answered in discovery and clinical settings is no longer limited to how much (quantitative), but rather what and to what extent relative to a previous formulation or study (qualitative). Knowledge about small molecule biomarkers of health and disease, endogenous markers of drug action, biomarkers of cellular and tissue toxicity is becoming an essential portion of intellectual property portfolios and regulatory submissions.

Mass Spec Lab has recently added a state of the art Xevo G2-S quadrupole time of flight (QTof) instrument with both high mass resolution and high mass accuracy for qualitative and quantitative analyses of highly complex samples.  Chromatographic separations prior to MS analysis also have a strong impact on data quality.  Mass Spec Lab utilizes ultra-high performance liquid chromatography (UPLC) and atmospheric pressure gas chromatography (APGC) separation before sensitive mass spectrometry (MS) detection.

Mass Spec Lab serves the pharmaceuticals industries in the following areas:

Surfactants and Excipients Analysis:  surfactants and excipients are widely used by the pharmaceutical industry in the formulation of final drug products.  The separation and identification of surfactants and excipients can be a challenge due to the chemical diversity and complexity of the sample matrix.  UPLC/MSMS is an excellent tool for sensitive detection and identification of a broad swath of the surfactants and excipients used in pharmaceutical compounding and formulation.  Many of these compounds lack UV chromophores precluding their detection with everyday LC/UV.  Tof MS is the best detector for these molecules.  The high polarity of these molecules e.g. HPMC, Povidone,polysorbate 80, poloxamers, results in high efficiency positive mode ionization which translates to high sensitivity.  The Tof detector maintains its sensitive and selective performance in the higher mass range of these polydisperse oligomers and polymers.  Distinctive MS fingerprint spectra with a multiplicity of characteristic peaks are easily identified.

Structural Characterization of Impurities and Degradants:  our instruments and expertise are well suited for characterization of raw material impurities and degradation products. With accuracy of mass detection at less than 5 ppm level, and high sensitivity for fragment characterization, as well as advanced data analysis software, we can tackle confounding structural characterization challenges.

Method development, validation, and transfer: whether your project involves a new supplement, formulation, small molecule drug, or biomarker we are equipped to help with analytical chromatography and mass spectrometry method development, method validation and transfer designed to meet internal and regulatory agency requirements.

Discovery and validation of biomarkers: scientific literature is replete with biomarkers of interest to biotechnology and pharmaceutical R&D teams. With state of the art instrumentation, there are many new “low hanging fruit” opportunities in biomarker discovery. Biomarkers can be critical to the understanding of baseline health, disease processes, supplement or drug induced changes, and toxicity. They can guide decisions about optimal formulation and active ingredient selection. Potent biomarkers now inspire nutraceutical supplements and novel treatments. Our highly experienced team and cutting edge technology can help you find new and validate previously published biomarkers.

Request more information or call us at 949-872-2724. 


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