A Rapid Qualitative Screening Method for Isoniazid Tablets Using Handheld NIR Spectrometers in Two Countries.

BACKGROUND: Isoniazid is a leading tuberculosis treating medication. Global supply chains provide essential medicines such as isoniazid to resource-limited areas. Ensuring the safety and efficaciousness of these medicines is essential to public health programs. Handheld spectrometers are becoming increasingly approachable in cost and usability. As supply chains expand, quality compliance screening of essential medications is necessary in site-specific locations. Here, a brand-specific qualitative discrimination analysis of isoniazid is approached by collecting data from two handheld spectrometers in two countries with the intent to build a multi-location quality compliance screening method for a brand of isoniazid. METHODS: Two handheld spectrometers (900-1700 nm) were used to collect spectra from five manufacturing sources (N = 482) in Durham, North Carolina, USA, and Centurion, South Africa. A qualitative brand differentiation method was established from both locations by applying a Mahalanobis distance thresholding method as a measure of assessing similarity. RESULTS: Combining data from both locations resulted in a 100% classification accuracy, at both locations, for brand 'A' and resulted in the four other brands classifying as dissimilar. Bias was found between sensors in terms of resulting Mahalanobis distances, but the classification method proved to be robust enough to accommodate. Several spectral peaks found in isoniazid references appear within the 900-1700 nm range, as well as variation in the excipients per manufacturer. CONCLUSIONS: Results show promise for compliance screening isoniazid as well as other tablets in multiple geographic locations using handheld spectrometers.

Establishment of instrument operation qualification and routine performance qualification procedures for handheld near-infrared spectrometers used at different locations within a laboratory network.

Quality assurance of finished pharmaceuticals is a necessity in ensuring the safety of consumers. There is a need for low-cost and portable rapid screening methods of pharmaceuticals in resource limited areas. Recent advances in technology have made handheld and low-cost diffuse reflectance spectrometers available to the public. While these handheld spectrometers offer advantages over benchtop spectrometers, the accuracy and repeatability must be assessed before these instruments can be used for quality assurance screening. Here, five handheld spectrometers of the same model were purchased, where an in-house installation qualification and operational qualification (IQOQ) was subsequently established for the instruments. Wavelength and photometric accuracy (and repeatability), spectroscopic noise, stray light, and bandpass were assessed between instruments. Results were found to be consistent between the spectrometers, passing IQOQ procedures, and were determined to be ready for field use. Once the handheld spectrometer's performance was verified, a practical and low-cost daily performance verification was established using common high density polyethylene vial caps on location in South Africa, Thailand, and the United States. A Mahalanobis distance-based classifier found the five spectrometers to be in agreement.