Aripiprazole Oral Solution

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BRIEFING

Aripiprazole Oral Solution. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed.

The liquid chromatographic procedure in the Assay was validated using the Zorbax Eclipse XDB-C18 brand of column with L1 packing. The typical retention time for aripiprazole is about 9 min.
The liquid chromatographic procedure in the Organic Impurities test was validated using the Inertsil ODS-3V brand of column with L1 packing. The typical retention time for aripiprazole is about 26 min.

(SM4: S. Dragan)

Case ID—SUB-752

USP REFERENCE STANDARDS FOR PURCHASE

USP Aripiprazole RS
USP Aripiprazole Related Compound F RS
USP Aripiprazole Related Compound I RS

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