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. 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. 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.
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