Abstract：OBJECTIVE To investigate the compatibility between medicinal rubber stoppers and 13-valent pneumococcal polysaccharide conjugate vaccine (PPCV 13). METHODS HPLC-DAD-CAD method was developed for determination of antioxidants, vulcanizates, palmitic acid and stearic acid in medicinal rubber stoppers and PPCV 13 injection. Taking antioxidant BHT, antioxidant 1010, antioxidant 1076, 4-tert-amylphenol, 2-chloro-4-(tert-pentyl)-phenol, sulfur, palmitic acid and stearic acid as indicators, extraction and migration tests were carried out to study the interaction between medicinal rubber stoppers and PPCV 13 and evaluate the compatibility. RESULTS HPLC-DAD-CAD method had the advantages of simple operation, fastness and sensitivity, which can meet the test requirements. In the extraction test, the investigated substances were lower than the analytical evaluation thresholds, the contents of leachables were not found in the migration test. CONCLUSION The antioxidants, vulcanizates, palmitic acid and stearic acid in the medicinal rubber stoppers have good compatibility with PPCV 13 injection.
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2022, Vol. 57 
