Evaluation of Stability Using One Versus Three Tubes for Each Quality Control Concentration in Matrix-Based Bioanalysis

Abstract

Aim: Contract research organizations and pharmaceutical firms have performed stability testing using one of two methods: storing in the freezer a single tube of matrix for each quality control concentration (Method 1), followed by aliquoting and analysis; and storing three tubes for each quality control concentration, followed by analysis (Method 2). This research project was conducted to determine if there were detectable differences between Method 1 and Method 2. Methodology: Five model drugs were selected: teriflunomide (stable compound) and acetyl salicylic acid, simvastatin, tenofovir alafenamide and valganciclovir (stability concerns). Samples were stored at -80°C for 1, 3 and 12 months and then analyzed. Samples were also placed at different locations within the freezer. Results: For the drugs tested, the results suggest that there is no significant difference in the outcome of stability testing, regardless whether Method 1 or Method 2 was followed.

Keywords:

• bioanalysis
• method validation
• regulatory
• small molecule
• stability

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.tandfonline.com/doi/suppl/10.2144/000112170

Acknowledgments

The authors wish to acknowledge the support received from Dr S Kassim, Director, Office of Study Integrity and Surveillance, CDER, FDA, which made this project possible, and B Folian, Regulatory Counsel, Office of Scientific Investigations, CDER, FDA, for his helpful comments and edits of this manuscript.

Disclaimer

The views expressed in this article do not necessarily represent the official views or policies of the FDA.

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.