BRIEFING

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

1. The liquid chromatographic procedure for the Assay was validated using the Chiralcel OD-R brand of column with L130 packing. The typical retention time for latanoprost is about 28 min.

2. The liquid chromatographic procedure for the Organic Impurities test was validated using the Zorbaxsil Silica brand of column with L3 packing. The typical retention time for latanoprost is about 18 min.

 (SM3: M. Jonnada)

 Case ID—SUB-460