Leuprolide Acetate EP Impurity D

Leuprolide Acetate EP Impurity D is chemically (6S,9S,12R,15S,18S)-18-((S)-2-((S)-3-(1H-imidazol-5-yl)-2-((S)-5-oxopyrrolidine-2-carboxamido)propanamido)-3-(1H-indol-3-yl)propanamido)-1-amino-6-((S)-2-(ethylcarbamoyl)pyrrolidine-1-carbonyl)-15-(4-hydroxybenzyl)-1-imino-9,12-diisobutyl-8,11,14,17-tetraoxo-2,7,10,13,16-pentaazanonadecan-19-yl acetate acetate. It is also known as [4-(O-Acetyl-L-serine)]leuprorelin Acetate. Leuprolide Acetate EP Impurity D is supplied with detailed characterization data compliant with regulatory guideline. Leuprolide Acetate EP Impurity D can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Leuprolide.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.