Stability, homogeneity and measurement uncertainty estimation of PVP-I solutions for the application on oro and nasopharynx against SARS-CoV-2

用于口腔和鼻咽部抗SARS-CoV-2的PVP-I溶液的稳定性、均匀性和测量不确定度评估

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Abstract

Aqueous solution containing different concentration (0.5, 0.6 and 1.0%) (w/v) of Polyvinyl pyrrolodon-Iodine (PVP-I) complex, a well-known antiseptic; is prepared and the stability and homogeneity of these solution is assessed as per the ICH Guidelines and International Harmonized Protocol respectively. The solutions were found to be sufficiently homogeneous and stable for a year at 25 °C (60%RH). Measurement uncertainty of the prepared PVP-I solutions were estimated by identifying possible sources of uncertainty using Ishikawa diagram and preparing uncertainty budget based on scope of calibration laboratory. The stable and homogenized PVP-I solution is to be used in a clinical trial for the application on oro and nasopharynx against novel SARS-CoV-2 Virus.

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