Source determination detects the origins of contaminants and is necessary to improve drug product quality and overall process quality.
Understanding what foreign material is present is only half of the story. True resolution cannot be reached without first understanding where the material came from, when it entered the manufacturing process, and how to prevent recurrence. Therefore, source determination is a critical test for drug developers that is capable of determining whether contaminants are present within pharmaceutical products and drug manufacturing processes.
Gateway Analytical provides source determination analysis so our customers can quickly find possible origins for their contamination problems. Our experts build reference material analysis databases with an all-of-the-above approach that may include microscopy, FTIR, Raman, and/or SEM-EDS depending on a project's unique needs. As a customer’s database becomes larger and more encompassing, the time required to conduct source determination tests on foreign material is reduced, resulting in improved processes and turnaround times.
Want to learn more about source determination and our database analysis capabilities? Contact us today.