Evaluation of stability using one versus three tubes for each quality control concentration in matrix-based...

Area of Science:

• Pharmaceutical Science
• Analytical Chemistry
• Drug Stability

Background:

• Contract research organizations and pharmaceutical firms utilize distinct methods for stability testing.
• Current methods involve either single-tube aliquoting (Method 1) or multiple-tube storage (Method 2) for quality control concentrations.

Purpose of the Study:

• To investigate and identify any significant differences in stability testing outcomes between Method 1 and Method 2.
• To assess the impact of different storage and aliquoting strategies on drug stability data.

Main Methods:

• Five model drugs were selected, including a stable compound (teriflunomide) and compounds with known stability concerns (acetyl salicylic acid, simvastatin, tenofovir alafenamide, valganciclovir).
• Samples were stored at -80°C for 1, 3, and 12 months, with variations in freezer location.
• Analysis was performed on samples prepared using both Method 1 and Method 2.

Main Results:

• Analysis of the tested drugs indicated no statistically significant differences in stability testing results between Method 1 and Method 2.
• The storage duration and freezer location did not introduce detectable variations impacting the comparison between the two methods.

Conclusions:

• The choice between single-tube aliquoting (Method 1) and multiple-tube storage (Method 2) for stability testing does not appear to significantly affect the reliability of the results for the tested compounds.
• Both methods are comparable for stability assessment of pharmaceutical compounds under the conditions studied.