Results and Analysis for the Proficiency Testing of the Density Determination Ability of Pharmaceutical Packaging Materials
Objective To improve the quality control ability of pharmaceutical packaging materials testing.Methods According to the requirements of the relevant documents of the China National Accreditation Service for Conformity Assessment(CNAS),the samples were prepared by a pharmaceutical packaging material manufacturer.The laboratory conducted proficiency testing of samples in accordance with the density determination method for pharmaceutical packaging materials in the general rule 4012 of the Chinese Pharmacopoeia(2020 Edition,Volume Ⅳ).After passing the homogeneity and stability test,the samples were randomly distributed to 41 institutions participating in the proficiency testing,and the evaluation results were collected.The laboratory's testing ability was evaluated by the z score.Results Among the 41 institutions participating in the proficiency testing,40 institutions were evaluated as satisfactory,with a satisfaction rate of 97.56％and a satisfaction range of 0.945-0.951 g/cm3.Conclusion Most laboratories have the ability to use the density measurement method of pharmaceutical packaging materials to determine the density of plastics.
万方数据
维普
