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.

含有不同浓度（0.5、0.6和1.0%）（w/v）聚乙烯吡咯烷酮-碘（PVP-I）复合物的水溶液，这是一种众所周知的防腐剂；制备并分别根据 ICH 指南和国际协调方案评估这些溶液的稳定性和均匀性。发现该溶液在 25 °C (60%RH) 下足够均匀且稳定一年。通过使用石川图识别可能的不确定性来源并根据校准实验室的范围准备不确定性预算来估计所制备的 PVP-I 溶液的测量不确定性。稳定且均质的 PVP-I 溶液将用于口腔和鼻咽部对抗新型 SARS-CoV-2 病毒的临床试验。