Quality Chemical Laboratories, LLC

Quality Chemical Laboratories is known for its capabilities in the development and validation of analytical methods for raw materials, drug substances, and drug products. With a strong focus on quality and precision, QCL employs cutting-edge technologies and a highly skilled team of scientists to offer com...

THE CHALLENGE: Develop at least one dosage form that avoids first-pass metabolism in the gut and all analytical methods using a limited quantity API. THE STRATEGY: This program began with typical quality by design elements including excipient compatibility studies and API characterization allowing formulations development personnel to select the right excipients for initial prototype development. In fact, one excipient caused an API stability problem. Since the excipient compatibility study design was binary, the stability issue was easily isolated to a single excipient and eliminated from future formulation inclusion.