Patent ID: 6828415
Filing Date: 2004-12-07
Classification: A61K,Y10S

Abstract:
A method for the preparation of a sterile Cetrorelix lyophilizate, said method comprising the steps of:(a) dissolving Cetrorelix having the amino acid sequence of AC-D-Nal(2)-D-pCl-Phe-D-Pal(3)-Ser-Tyr-D-Cit-Leu-Arg-Pro-D-Ala-NH2 (SEQ ID NO: 1) in aqueous acetic acid to form a solution, (b) diluting said solution with water for injection, (c) adding bulking agent to the solution, wherein said solution has a pH range between 2.5-3.0, and (d) sterile filtering, dispensing into injection vials and lyophilizing the solution thereby obtaining a sterile Cetrorelix lyophilizate.