US FDA CFR Testing

The Code of Federal Regulations (CFR) is a series of rules established by the US government that apply to industries regulated by the US Food and Drug Administration. Toxikon offers an extractable analysis for residuals test that meets CFR standards.

Understanding CFR Testing

The purpose of the study is to analyze total extractables. Extract solutions are evaporated to dryness and residues are weighed. Residue per surface area is calculated.

Testing categories and specifications

Test NameSample NeededTurn-Around Time
Total Extractables - Rubber Articles Intended for Repeated Use, CFR 177.2600150 cm²/extract2-3 weeks