Raw Materials Analysis

McCrone Associates offers numerous services for the identification of contamination particles. Often, the source of the particles can be traced to the raw materials used in the production of the product or the packaging used to store the material. Our staff can assist in root cause investigations and coordinate raw materials analyses of source materials and product issues. We also provide consulting services for characterization of raw materials as part of larger failure analysis. Some recent projects where we have assisted in solving problems through raw materials analysis:

• Identification of a haze observed in a pharmaceutical raw material that failed clarity testing
• Confirmation of correct polymer used in the packaging of a pharmaceutical device
• Identification of dark specks in a cosmetic product tied to an ingredient in the formulation
• Characterization of residue found in plating baths
• Identification of fibers found in a pharmaceutical active ingredient, traced to a filter used in production
• Particle size analysis of tablet components that were failing dissolution testing
• Characterization of product contaminants originating from storage containers, such as paint chips and metal particles from metal drums

Our services begin with an evaluation of your problem and samples and continue with analysis and consulting. If needed, we also offer on-site investigation and coordination of additional services.