A shelf life stability program has been initiated for D-Tryp-LHRH to determine the stability of the sterile liquid formulation. The formulation is being studied at room temperature, freezer and refrigeration. The duration of the study will depend on the stability of the sample but will probably last from 2-3 years. A stability indicating HPLC assay has been developed and is being used to determine the stability of the formulation. The pH is also being monitored at each time interval. Preformulation studies were conducted to determine the loss during filtration and if the peptide bind to the glass vials.
