Comparative Physical Stability Observations of Co-Amoxiclav TSS Residual Vacuum Dust at Various Relative Humidity (RH) Levels

Abstract

This study descriptively compared physical stability observations of residual vacuum-molded dust collected from a Co-Amoxiclav TSS process under different relative humidity (RH) conditions and packaging configurations. The source study did not document the exact amoxicillin-to-clavulanate ratio, batch composition, or whether the residual material was representative of a finished pharmaceutical product or of isolated active pharmaceutical ingredients; therefore, the findings are restricted to the material tested. Nine 5-g samples were allocated to low (22–30%), moderate (50–65%), and high RH (65–80%) environments, with one sample for each RH–packaging combination: parchment paper (P1), parchment paper plus a zip-lock bag (P2), and parchment paper plus a zip-lock bag with silica gel (K1). Samples were observed on Days 0, 3, and 5 using organoleptic assessment and gravimetric weight measurement. Because each RH–packaging combination had only one experimental unit and no independent replication, results were interpreted descriptively without inferential statistical testing. Greater visible and gravimetric changes were observed in P1 and P2 at moderate and high RH, whereas K1 generally showed smaller changes and preserved a fine white powder appearance. These observations support the practical importance of moisture-protective packaging for hygroscopic pharmaceutical materials, but they do not establish chemical degradation because no assay of active substances, degradation products, or moisture content was performed. Appropriate storage and preservation of medicine quality support SDG 3 (Good Health and Well-Being); reducing avoidable quality loss and pharmaceutical waste may also contribute to SDG 12 (Responsible Consumption and Production) when supported by broader lifecycle evidence.