Excipient Level Justification

Excipient Level, Decomposition contaminates, and residual solvent level justifications.

Pharmaceutical products typically use excipients and solvents in processing and formulation. In some cases, the concentration or levels of these excipients, decomposition contaminates, and residual solvents must be justified and documented. Regulatory agencies, such as the United States Food and Drug Administration (FDA), require that the level of these substances above the recommended guidelines of the inactive ingredient guide be scientifically justified and supported.

Stability studies can turn up unexpected results in products. After identification, Superior Toxicology has justified the specification increases for many impurities for many APIs. These reports will be economical, concise and just what you need to keep your development project on time.

Superior Toxicology & Wellness’ toxicologist can perform the appropriate literature review and prepare the supporting documentation.