1311.47 (free base)
6-d-Tryptophan-, 4,4′-methylenebis[3-hydroxy-2-naphthalenecarboxylate] (salt);
5-Oxo-l-prolyl-l-histidyl-l-tryptophyl-l-seryl-l-tyrosyl-d-tryptophyl-l-leucyl-l-arginyl-l-prolylglycine amide, 4,4'-methylenebis[3-hydroxy-2-naphthoate] (salt) [124508-66-3]
BRIEFING
Triptorelin Pamoate. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed. The proposal for this drug substance, which appeared in PF 48(5) [Sep.–Oct. 2022] has been canceled and is being replaced with a new proposal.
-
The liquid chromatographic procedures in the Assay and the test for Triptorelin-Related Impurities are based on analyses performed with the XTerra RP18 brand of column with L1 packing. The typical retention times for pamoic acid and triptorelin in the Assay are about 3.4 and 8.8 min, respectively. The typical retention times for pamoic acid and triptorelin in the test for Triptorelin-Related Impurities are about 9 and 31 min, respectively.
-
The liquid chromatographic procedure in the test for Acetic Acid is based on analyses performed with the Dionex IonPac AG-10 brand of precolumn with L112 packing and the Dionex IonPac AS-10 brand of analytical column with L31 packing. The typical retention time for acetic acid is about 6 min.
(BIO1: J. Zhang)
Correspondence Number—C327633