Investigation Of Iodine Disinfectants Usage And The Development Of Available Iodine Reference Material

Iodine disinfectant is an anti-microbiological agent that is effective,broad-spectrum,safe.The majority of iodine disinfectants manufacturers are small to medium sized enterprises with low technology.The lack of proficiency test leads to incomparable and inaccurate judgement of test results of similar products across the nation.The iodine disinfectants market could be regulated by developing available iodine reference material,and therefore to ensure the accuracy of available iodine test results,avoid quality disputes,and supervise facilitate quality.In this study,the available iodine reference material preparation scheme was set up by investigating commercially available iodine disinfectants.The available iodine reference material study was complete after homogeneity and stability tests,and collaborative calibration between multiple laboratories.The main research contents from this thesis are stated as follow:Objective:To develop available iodine reference material in disinfectants.To conduct the uncertainty assessment for homogeneity,stability and characterization.Methods:Establish the production scheme for available iodine reference material via investigating 413 commercially available iodine disinfectants.Complete the reference material development.Five-hundred ampoules of available iodine reference material was prepared and 15 of them was randomly chosen for testing in triplicates.The homogeneity was analyzed using ANOVA.The long term stability was evaluated by testing the material at 1,2,3,6,9,12,18 and 24 months after preparation.Short term stability was evaluated by testing available iodine concentration after storing at 40 ? and-40 ? for 0,3,7 and 14 days.The value of the reference material prepared was determined jointly by 7 laboratories using 2 methods.Data was validated by methods of statistics.The standard value was calculated.The uncertainty component induced by available iodine reference material homogeneity,stability and characterization was calculated.The overall uncertainty and expanded uncertainty were evaluated.The characteristic quantity of this reference material was valued.Results:Being the main type of iodine disinfectant,iodophor disinfectant consists 91.8%of the market.In order to enhance the effect,36.3%of iodine disinfectants contain other components.79.9%of all products in this investigation contains about 0.5%(5 g/L)iodophor.Thirty four iodine disinfection samples were tested and the defect rate was 55.9%.The available iodine reference material was prepared by polyalcohol ether iodine at a mass fraction of 0.5%.The tests showed no impurities affecting available iodine concentration.The inter-and intra-bottle test results showed high homogeneity.The product has a good stability over both long term and short term storage.Statistical analysis showed that the value of available iodine in this reference material was defined as 0.508%.Synthesize the uncertainty introduced by the homogeneity,stability and characterization,the combined uncertainty was 0.002%and the expanded uncertainty was 0.004%.The characteristic quantity is expressed as(0.508±0.004)%(k=2).Conclusion:This study has completed the development of available iodine reference material and evaluated the uncertainty of it.This reference material could be used in proficiency test or collaborative tests.It is helpful for supervising iodine disinfectants market and avoiding quality disputes.