BRIEFING

 Arsenic Trioxide. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed. The liquid chromatographic procedure in the test for Limit of Arsenic Pentoxide was validated using the Dionex Ionpac AG 11 brand of guard column with L61 packing and the Dionex Ionpac AS 11 brand of analytical column with L61 packing. The typical retention time for arsenic pentoxide is about 18 min.

 Description and solubility information: White to off-white powder. Soluble in 1 N sodium hydroxide.

 (SM3: V. Durga Prasad)

 Case ID—SUB-1587