Analytical protocol for the sensitive determination of mannitol, sorbitol and glucose containing powders in pharmaceutical workplaces by ion chromatography using a pulsed amperometric detector

Abstract

Workers in the pharmaceutical industry can potentially be exposed to airborne dusts and powders that can contain potent active pharmaceutical ingredients (API). Occupational hygienists and health and safety professionals need to assess and ultimately minimise such inhalation and dermal exposure risks. Containment of dusts at source is the first line of defence but the performance of such technologies needs to be verified, for which purpose the good practice guide: assessing the particulate containment performance of pharmaceutical equipment, produced by the International Society for Pharmaceutical Engineering (ISPE), is a widely used reference document. This guide recommends the use of surrogate powders that can be used to challenge the performance of such containment systems. Materials such as lactose and mannitol are recommended as their physical properties (adhesion, compactability, dustiness, flow characteristics and particle sizes) mimic those of API-containing materials typically handled. Furthermore they are safe materials to use, are available in high purity and can be procured at a reasonable cost. The aim of this work was to develop and validate a sensitive ion-chromatography based analytical procedure for the determination of surrogate powders collected on filter samples so as to meet analytical requirements set out in this ISPE guide.

Study on detection methods for sorbitol

“…Butler et al [19] developed an analytical protocol for the sensitive determination of mannitol, sorbitol and glucose containing powders in pharmaceutical workplaces by ion chromatography using a pulsed amperometric detector. De Castro et al [20] proposed the direct determination of sorbitol and sodium glutamate by attenuated total reflectance Fourier transform infrared spectroscopy in the thermostabilizer employed in the production of yellow-fever vaccine.…”

Impedimetric Enzyme‐Free Detection of Glucose via a Computation‐Designed Molecularly Imprinted Electrochemical Sensor Fabricated on Porous Ni Foam

“…[1,2] As a matter of fact, glucose analysis also finds extensive use in other fields beyond blood sugar detection, such as food and pharmaceutical inspection, environmental pollution monitoring, and bioprocess control. [3][4][5] In this context, various advanced approaches including chromatography, [6,7] optical analysis, [8][9][10] and electrochemical (bio)sensors [11][12][13][14][15] have been explored for the detection of glucose. Among these methods, fabricating non-enzymatic electrochemical sensors is considered as a promising strategy to realize the target determination, because they exhibit some attractive properties of high performance, fast response, low cost, and miniaturized devices.…”