Spectral Analysis of Injectable Depot Medroxyprogesterone Acetate From the International Market With Diffuse Reflectance Spectrometers: Potential Public Health Implications With Benchtop and Handheld Spectrometers

Abstract

Depot-medroxyprogesterone acetate (DMPA) is an essential medication used as a form of family planning by millions around the world. Diffuse reflectance spectroscopy (DRS) has a long history as a quality assurance measure for raw ingredient verification in pharmaceutical manufacturing. There are a multitude of DMPA manufacturers in the global marketplace. Prudent supply chain management requires identification of potential suppliers that can be contacted if a current supplier is unavailable. Here, DRS data were collected with benchtop (350–2500 nm) and handheld (900–1700 nm) spectrometers for 16 brands of DMPA. Spectra from sample vials ( N = 262) are compared through principal component analysis and Mahalanobis distances. The benchtop spectrometer proved to be an efficient gauge of the similarities and differences amongst DMPA brands, with subcontracted manufacturers resulting in very similar results to the primary manufacturers. The handheld spectrometer offers advantages in portability and cost and was shown to be an effective brand discrimination tool but was less reliable in the context of identifying potentially suitable supply chain substitution options of DMPA due to several key DMPA spectral features appearing just outside of the handheld spectrometer's range. Data collected from the benchtop spectrometer was used to identify several potential supply chain substitutions, dependent on various other subsequent due-diligence activities (i.e., product documentation reviews and manufacturing site audits). These potential substitutions can be shortlisted for further auditing review prior to being identified as a potential supply chain substitution.