BRIEFING

 Eteplirsen Injection. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is being proposed.

1. The procedure in Identification A was validated using the XBridge BEH300 C4 brand of column with L26 packing.

2. The liquid chromatographic procedure in the Assay and Organic Impurities test was validated using the XBridge C-18 brand of column with L1 packing. The typical retention time for eteplirsen is about 6 min.

3. The liquid chromatographic procedure in the N-Tail Impurity test was validated using the ProPac SCX-10 brand of column with L6 packing. The typical retention time for eteplirsen is about 11 min.

 (BIO1: J. Zhang)

 Case ID—SUB-735