Stability of azacitidine in lactated Ringer's injection frozen in polypropylene syringes. 1989

J den Hartigh, and H C Brandenburg, and P Vermeij
Department of Clinical Pharmacy and Toxicology, University Hospital, Leiden, the Netherlands.

The stability of azacitidine diluted in lactated Ringer's injection was studied. Azacitidine was reconstituted with ice-cold lactated Ringer's injection to concentrations of 2.0 and 0.5 mg/mL and stored in polypropylene syringes at -20 degrees C. On days 1, 3, 7, and 14, the solutions were thawed over 30-45 minutes and the azacitidine concentration was determined by high-performance liquid chromatography immediately after thawing and one, three, and six hours later. Other studies were conducted at 37, 20, and 0-4 degrees C to determine decomposition rate constants for azacitidine at both concentrations. Hydrolysis of azacitidine resulted in a biphasic decline when the log of the percentage of drug remaining was plotted against time. No substantial decomposition occurred during storage at -20 degrees C. In thawed samples, azacitidine concentrations decreased to 90% of the initial concentrations within three hours after reaching room temperature; similar decreases in concentration were seen in nonfrozen samples stored at room temperature. The results of these studies indicate that azacitidine solutions in lactated Ringer's injection can be stored in polypropylene syringes at -20 degrees C for two weeks without decomposition. The thawed solutions should be used within three hours.

UI MeSH Term Description Entries
D007267 Injections Introduction of substances into the body using a needle and syringe. Injectables,Injectable,Injection
D011126 Polypropylenes Propylene or propene polymers. Thermoplastics that can be extruded into fibers, films or solid forms. They are used as a copolymer in plastics, especially polyethylene. The fibers are used for fabrics, filters and surgical sutures. Propene Polymers,Propylene Polymers,Hostalen,Marlex,Marlex Polypropylene,Polypro,Polypropylene,Prolene,Polymers, Propene,Polymers, Propylene,Polypropylene, Marlex
D002851 Chromatography, High Pressure Liquid Liquid chromatographic techniques which feature high inlet pressures, high sensitivity, and high speed. Chromatography, High Performance Liquid,Chromatography, High Speed Liquid,Chromatography, Liquid, High Pressure,HPLC,High Performance Liquid Chromatography,High-Performance Liquid Chromatography,UPLC,Ultra Performance Liquid Chromatography,Chromatography, High-Performance Liquid,High-Performance Liquid Chromatographies,Liquid Chromatography, High-Performance
D004355 Drug Stability The chemical and physical integrity of a pharmaceutical product. Drug Shelf Life,Drugs Shelf Lives,Shelf Life, Drugs,Drug Stabilities,Drugs Shelf Life,Drugs Shelf Live,Life, Drugs Shelf,Shelf Life, Drug,Shelf Live, Drugs,Shelf Lives, Drugs
D004356 Drug Storage The process of keeping pharmaceutical products in an appropriate location. Drug Storages,Storage, Drug,Storages, Drug
D005615 Freezing Liquids transforming into solids by the removal of heat. Melting
D001374 Azacitidine A pyrimidine analogue that inhibits DNA methyltransferase, impairing DNA methylation. It is also an antimetabolite of cytidine, incorporated primarily into RNA. Azacytidine has been used as an antineoplastic agent. Azacytidine,5-Azacytidine,NSC-102816,Vidaza,5 Azacytidine,NSC 102816,NSC102816
D013594 Syringes Instruments used for injecting or withdrawing fluids. (Stedman, 25th ed) Hypodermic Syringes,Syringe, Karman,Hypodermic Syringe,Karman Syringe,Syringe,Syringe, Hypodermic,Syringes, Hypodermic
D013696 Temperature The property of objects that determines the direction of heat flow when they are placed in direct thermal contact. The temperature is the energy of microscopic motions (vibrational and translational) of the particles of atoms. Temperatures

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