BRIEFING

 European Elder Berry Juice Concentrate. Because there is no existing USP monograph for this dietary ingredient, a new monograph based on validated methods of analysis is being proposed.

1. The liquid chromatographic procedure in the test for Content of Anthocyanosides is based on analyses performed using the Waters Symmetry C18 brand of column with L1 packing. The typical retention times at 535 nm for cyanidin-3-O-sambubioside-5-O-glucoside, cyanidin-3,5-di-O-glucoside, cyanidin-3-O-sambubioside, cyanidin-3-O-glucoside, and cyanidin are 4.7, 5.3, 8.5, 10.0, and 20.4 min, respectively. The typical retention times at 365 nm for cyanidin-3-O-sambubioside-5-O-glucoside, cyanidin-3-O-sambubioside, cyanidin-3-O-glucoside, rutin, isoquercitrin (quercetin-3-O-glucoside), kaempferol-3-O-rutinoside, isorhamnetin-3-O-rutinoside, kaempferol-3-O-glucoside, quercetin, and kaempferol are 4.7, 8.5, 10.0, 17.1, 18.2, 20.4, 21.0, 21.6, 28.5, and 30.1 min, respectively.

2. The liquid chromatographic procedure in the test for Content of Dextrose and Fructose is based on analyses performed using the Thermo Scientific Hypersil APS-2 brand of 5-µm column with L8 packing. The typical retention times for fructose and dextrose are 7.9 and 9.7 min, respectively.

3. The liquid chromatographic procedure in the test for Organic Acids is based on analyses performed using the Waters YMC ODS-AQ brand of column with L1 packing. The retention times for tartaric acid, quinic acid, malic acid, shikimic acid, citric acid, and fumaric acid are 2.1, 2.2, 2.9, 3.1, 5.7, and 6.6 min, respectively.

4. USP is seeking additional input and supporting data from stakeholders about the composition and content of anthocyanins, organic acids, and sugars in European Elder Berry Juice Concentrate in order to confirm the limits proposed herein.

 (BDSHM: M. Monagas)

 Case ID—SUB-446