Extraction of Antioxidant Degradation Products from High-density Polyethylene Bottles and Migration Studies in Soybean Oil(for Injection)
Objective:To investigate the compatibility of antioxidant degradation products in HDPE bottles with soybean oil for injection and to assess the safety risk of the three antioxidant degradation products in HDPE bottles.Methods:A gas chromatography-mass spectrometry(GC-MS)method was developed and validated for the determination of the degradation products in HDPE bottles and the migration of the degradation products into soybean oil.Results:The method was well applicable,accurate,stable and methodologically compliant.The method was applied to three batches of soybean oil for injection and DBP,DBB and DBHBA were not detected under the accelerated test(40℃±2℃,75%±5%,left for 0,3 and 6 months)and long-term test(25℃±2℃,60%±10%,left for 3,6,9 and 12 months)test conditions.Conclusion:The antioxidant degradation products in HDPE bottles failed to migrate into soybean oil for injection,the package is compatible with soybean oil for injection and provides a viable basis for its safety risk assessment.
soybean oil for injectionhigh density polyethylene bottlecompatibilityGC-MS
万方数据
维普
