Expanding Our Analytical Capabilities To Include HPLC/Mass Spectrometry

Singota Solutions, a full-service CDMO specializing in aseptic manufacturing and supply chain services, announced the addition of HPLC/mass spectrometry to their analytical capability. Singota currently provides a wide range of lab assays and activities to support GMP manufacturing as well as formulation and method development. The new Agilent 1290 Infinity II Bio-inert uHPLC with the XT Single Quad Mass Spectrometer will add significant capabilities to Singota’s ability to support formulation and analytical method development and transfer activities.

Ryan Memmer, Quality Control & Product Development Manager at Singota Solutions, stated he was looking to “provide improved early characterization for clients to allow for better identification of related substances and impurities”. The XT single quad mass spectrometer is able to measure the mass of even large peptides, and has the capability of generating high-resolution mass data, making it a perfect fit for the early-stage development work routinely performed in his lab. This is particularly important when trying to understand the stability of the drug substance molecule being developed. When conducting stability studies or determining API purity prior to formulating, “the addition of mass spectrometry services allow us to expand our knowledge and understanding for our clients” in terms of the identity of new peaks that might develop. Another benefit is the ability to correlate related peaks when transferring analytical methods from outside laboratories.

An additional benefit is the inclusion of both the state-of-the-art Agilent 1290 Infinity II Bio-inert uHPLC system with the new mass spectrometer. Memmer said that “this system is ideally suited for challenging method transfer projects as the software is able to compensate for subtle differences when comparing different manufactures of HPLC, allowing for seamless transfer of methodologies from other labs.”

He has been pleased with the results thus far, stating that the new HPLC “allows for highly replicable results when compared to the methods being transferred from other HPLCs.”

Singota Solutions is a Contract Development and Manufacturing Organization (CDMO) dedicated to helping clients overcome obstacles at any phase of the drug development pipeline. Specializing in comprehensive services, Singota Solutions expedites the progression of products through the drug development stages, advancing them toward clinical trials with speed and efficiency.