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Eteplirsen
C364H569N177O122P30 10305.7
 [1173755-55-9]

BRIEFING

 Eteplirsen. Because there is no existing USP monograph for this drug substance, 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-734

USP REFERENCE STANDARDS FOR PURCHASE

USP Eteplirsen RS
USP N-1(A5 or A6) Eteplirsen RS
USP N-1(C27) Eteplirsen RS
USP N-1(T24, T25 or T26) Eteplirsen RS
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