Raw Material Characterization Services at Impact Analytical
Raw material characterization plays an important part in the quality control process of product manufacture or development, ensuring that contaminants, residual solvents, catalysts, water, particles, and/or degradants meet specifications.
Impact Analytical has a full suite of analytical capabilities to characterize all classes of raw materials. We have the experience to develop & validate new methods for characterization. We can transfer these methods to the client, or if needed, provide raw material support on a routine basis.
When you work with us, our experts will first consult with you to determine your specific needs. Discussions will include types of chemical analyses required, sample amounts, sample solubility, sample handling restrictions, and level of reporting required. The level of reporting can be an informal one-page document, or more formal reports, including certificates of analysis, such as our standard ISO report, GLP/cGMP report for Federal agency (FDA and EPA) requirements in the United States, or REACH report for European Union requirements.
Examples of raw materials we have experience characterizing include:
- Drug Product Excipients
- Solvent Purity
- Drug Substance Intermediates
- Catalyst Materials