DEFINITION

Goserelin Implants are extended-release formulations of a sterile dispersion of Goserelin Acetate in a matrix of d,l-lactic and glycolic acids copolymer (PLGA) that is subcutaneously injected. The content of the PLGA and other ingredients is process-specific, and their identity and properties are determined by validated methods. The quality of Goserelin Acetate meets the compendial standard. Goserelin Implants contain NLT 90.0% and NMT 110.0% of the labeled amount of goserelin (C₅₉H₈₄N₁₈O₁₄).