In Pursuit of Excellence: Synergy Bioscience's E&L Study Reaffirms Our Commitment to Pharmaceutical Safety

Synergy Bioscience, a Contract Research Organization specializing in product development, analytical chemistry, microbiology testing, and quality system compliance consulting services, recently completed an important project that highlights our core expertise. We designed and executed an Extractables and Leachables (E&L) Study for medical-grade storage bags used to hold Active Pharmaceutical Ingredients (API) Concentrate. This study underscores our unwavering commitment to pharmaceutical safety.

Objective of the Study

The primary goal was to conduct a comprehensive E&L analysis to confirm the safety of API concentrates when stored in these medical grade bags. We aimed to identify and assess any substances that could potentially leach into the API concentrate from the bag’s material.

Initial Steps and Planning

The project began by identifying all elements of the storage system that could come into direct contact with the API concentrate, including the container, tubing, and other components. We created a customized E&L plan and a risk assessment matrix to evaluate the bags under various conditions.

Methodology and Testing

Utilizing a range of solvents with different polarities, controlled extraction studies were conducted. The extracted samples were rigorously analyzed, both qualitatively and quantitatively, and validated for accuracy, specificity, detection limits, and other key parameters.

Toxicological Evaluation

A separate phase of the project examined the safety aspects of the substances found in the study. We relied on extensive internal documentation to guide our evaluations, including pre-established guidelines for container closure systems and risk management strategies.

Tools and Team

Our study employed cutting-edge analytical tools such as Stability Chambers, Solvent Extractors, TOC, Orbitrap LC-MS/MS, GC-MS, IC-MS, and ICP-OES. An interdisciplinary team of seven internal and three external experts oversaw the project.

Key Findings

• The in-depth study identified 21 potential substances that could leach into the API concentrate.
• Calibration curves showed strong linearity and detection limits were confirmed at sub-ppm levels.
• A detailed 157-page technical report was produced, summarizing the methodologies, findings, and safety assessments.

Conclusion

Our E&L study serves as a strong testament to Synergy Bioscience's commitment to maintaining the highest safety standards in pharmaceuticals. It reaffirms our dedication to using advanced analytical methods and technologies to tackle pharmaceutical challenges. This project marks another milestone in our ongoing mission to be leaders in pharmaceutical safety and innovation. Join us as we continue to shape the future of healthcare, one groundbreaking project at a time.