Analytical Method Development and Support

Method development and validation are critical parts of the development of an API manufacturing process. Both tasks are essential parts of the CMC plan. Our team of experts will provide a broad range of tests, develop specific methods for your molecule(s) and then validate them. We have experience with:

• UPLC and HPLC by UV-, RI-, Fluorescence, Radiochem and ELSD-Detection
• LC/MS
• Maldi-TOF MS
• Microbiological Testing including Endotoxins and Bioburden
• Heavy Metals by ICP
• Melting Temperature
• Multi-nuclear NMR, including ¹H, ¹³C, ¹⁹F and ³¹P
• Residual Solvents by Headspace GC
• Sodium content by ICP
• Palladium and other catalysts
• Water Content by Karl Fischer

We will develop an impurity identification process that is also important for the specification setting and validation. A forced degradation study is helpful in this impurity identification process and included as a part of all method validation work.

Risk assessment of the analytical methods will address the question of resolution and sensitivity. It answers the question: How good are your analytical methods? We strongly advocate starting this early in the development in order to avoid delays to your program timelines and additional costs.