Comparison of Analytical Techniques for Thermal Stability Analysis of β-Cyclodextrin for an Ebola Virus Infection Treatment

ABSTRACT Each New Drug Application filed with the Food and Drug Administration (FDA) must include the analytical procedures to ensure the identity, strength, quality, purity, and potency of a drug substance and drug product. The BSN389 drug product (being developed to treat Ebola virus infections) includes beta cyclodextrin. Evidence must be provided that the analytical procedures used in testing BSN389 meet proper standards of accuracy, sensitivity, specificity, and reproducibility and are suitable for their intended purpose. The Bootstrap Error-adjusted Single-Sample Technique (BEST) software was used to compare the quantitative and qualitative power of IR and 1 H NMR to differentiate new and partially decomposed samples of beta cyclodextrin, and the best assay will be incorporated into the thermal stability protocol for ВCD.