the preferred CDMO for pharma and biotech companies

• Overview of Combination Products & Latest Regulatory Guidance
• Understand What IS and IS NOT a Combination Product  
• Application of Combination Product Regulation 
• cGMP's, Quality Systems, and Your CDMO 
• Q&A Session Following Presentation  

• Overview and Definitions
• Time Frames for Performing Admixture Studies
• FDA Filing and Approval Processes
• Lessons Learned
• Q & A Session Following Presentation  

Inductively Coupled Plasma Mass Spectrometry (ICP-MS) is a quickly growing technique in the pharmaceutical industry for its ability to deliver accurate and precise measurements of many metals within minutes. The general flow of analysis for ICP-MS starts with sample preparation, which can be as simple as diluting the sample material into a dilute acidic matrix or involve more complex preparation schemes that utilize extraction or digestion techniques. After the sample is in solution, it is aspirated into a fine, aerosolized mist that is introduced into the argon plasma. The argon plasma ionizes the atoms which then are streamlined towards the detector with the help of ion-focusing cones and lenses. Multiple configurations, including collision and reaction cell gases, can be interchanged to optimize the instrument’s ability to detect the analyte in both simple and complex sample matrices. The versatility, short analysis time, and ability to measure many elements at once make ICP-MS a better alternative to the older stand-by methods of flame and graphite furnace atomic absorption. In this white paper, we will highlight several applications of ICP-MS in the pharmaceutical industry that capitalize on the technique’s versatility outside of the scope of elemental impurities.