US EPA

4837204 

Journal Article 

Development of an HPLC/UV method for the evaluation of extractables and leachables in plastic: Application to a plastic-packaged calcium gluconate glucoheptonate solution 

Legrand, P; Desdion, A; Boccadifuoco, G; Dufaÿ Wojcicki, A; Worsley, A; Boudy, V; Dufay, SG 

2018 

Yes 

Journal of Pharmaceutical and Biomedical Analysis
ISSN: 0731-7085
EISSN: 1873-264X 

155 

298-305 

English 

29679874 

10.1016/j.jpba.2018.03.044 

WOS:000433267700036 

Calcium gluconate glucoheptonate (GGCa) is known to interact with glass containers, leading to the leaching of aluminum from the glass into the solution at toxic level. Therefore, plastic containers seem to be a preferable packaging alternative. Nevertheless, plastics contain potentially toxic additives which could be released into the solution. In order to study content container interaction between GGCa and two plastic containers (polypropylene PP and polyethylene PE containers), an HPLC-PDA method was developed to separate, detect and quantify eleven additives commonly found in plastic materials, with good limit of detection and quantification. This method was then applied to evaluate the compatibility between GGCa and the two plastic containers. After 3 months of storage at 25 °C, none of the eleven additives were detected in GGCa solutions. The safety concern threshold (SCT) and of the analytical evaluation threshold (AET) were evaluated to discriminate the need to identify and qualify unknown peaks.