Patent ID: 8431735

Claim:
A four stage inexpensive method of preparing pharmaceutical grade Melphalan2HCl utilizing industrial grade reactants, comprising: a) reacting N-phthaloyl-4-[bis(2-hydroxyethyl) amino]-phenylalanine ethyl ester with phosphorous oxychloride to obtain a chlorinated reaction product; b) obtaining a hydrolysis/salt formation precipitate of said chlorinated reaction product by reacting same with hydrochloric acid followed by reaction with an alkali hydroxide; c) purifying said hydrolysis/salt formation precipitate by dissolving in hydrochloric acid, adding active charcoal, adding alkali hydroxide, filtering and washing with deionized water, slurrying with isopropyl ether; repeating said purifying step, adding distilled water, lyophilizing and milling to obtain a product; and d) obtaining a pharmaceutical grade Melphalan-2HCl by: dissolving the product of step c) adding HCl, freezing until frozen, and lyophilizing.