Formulación y estudio de estabilidad de acetilcolina 20 mg, liofilizado para solución oftálmica

the formulation and manufacturing technology of acetylcholine 20 mg, lyophilized for opthalmic solution, of national production, was developed aimed at subtituting the import of the commercial product. the product′s stability study conducted by the accelerated method and corroborated by the shelf life study was presented according to the method of analysis reported in the usp xxiii. it was demonstrated that the drug has the pharmaceutical quality required for this type of sterile preparations and that it fulfils all the quality specifications of the usp xxiii. an expiration date was obtained by the accelerated method of 3 years at ambient temperature, which was proved in the shelf life study.