DEFINITION

Fish Oil Containing Omega-3 Acids Delayed-Release Capsules are enteric-coated Capsules that contain NLT 95.0% and NMT 105.0% of the labeled amount of Fish Oil Containing Omega-3 Acids where Fish Oil Containing Omega-3 Acids is the purified, winterized, and deodorized fatty oil obtained from fish of the families Engraulidae, Carangidae, Clupeidae, Osmeridae, Scombridae, and Ammodytidae. The omega-3 acids are defined as the following: alpha-linolenic acid (C18:3 n–3), moroctic acid (C18:4 n–3), eicosatetraenoic acid (C20:4 n–3), eicosapentaenoic acid (EPA) (C20:5 n–3), heneicosapentaenoic acid (C21:5 n–3), docosapentaenoic acid (C22:5 n–3), and docosahexaenoic acid (DHA) (C22:6 n–3). It contains NLT 28.0% (w/w) of total omega-3 acids, expressed as free acids, consisting of NLT 13.0% of EPA and NLT 9.0% of DHA. Suitable antioxidants in appropriate concentrations may be added.