Stability of azacitidine in infusion fluids. 1984

Y W Cheung, and B R Vishnuvajjala, and N L Morris, and K P Flora

The stability of azacitidine in four infusion fluids was studied. Azacitidine was reconstituted and diluted to final concentrations of 0.2 mg/ml and 2.0 mg/ml in glass bottles and plastic i.v. bags containing 0.9% sodium chloride injection, 5% dextrose injection, lactated Ringer's injection, or Normosol -R. All admixtures containing azacitidine 2.0 mg/ml and both drug concentrations in Normosol -R were prepared in glass bottles only. The pH of each solution was measured before mixing, immediately after mixing, and after six hours. Duplicate samples of each solution were removed for assay by high-performance liquid chromatography at zero time, then at hourly intervals for six hours, and again at 25 hours. Three experimental runs were performed for each combination of drug concentration, infusion fluid, and type of container. The percentage of initial (zero time) concentration remaining was determined and plotted versus time. This plot was used to calculate the t90 (time at which 90% of the initial concentration remained) for each solution. The t90 values did not exceed three hours for any of the solutions studied. At the 0.2 mg/ml concentration, the t90 value in 5% dextrose injection (0.8 hours) was much smaller than that of the other solutions, which had t90 values of about two hours. In plastic bags, the percentage of initial azacitidine concentration remaining after six hours was less in 5% dextrose injection than in any other solution. The t90 values for all solutions containing azacitidine 2.0 mg/ml were similar, ranging from 2.4 to 3.0 hours.(ABSTRACT TRUNCATED AT 250 WORDS)

UI MeSH Term Description Entries
D007263 Infusions, Parenteral The administration of liquid medication, nutrient, or other fluid through some other route than the alimentary canal, usually over minutes or hours, either by gravity flow or often by infusion pumping. Intra-Abdominal Infusions,Intraperitoneal Infusions,Parenteral Infusions,Peritoneal Infusions,Infusion, Intra-Abdominal,Infusion, Intraperitoneal,Infusion, Parenteral,Infusion, Peritoneal,Infusions, Intra-Abdominal,Infusions, Intraperitoneal,Infusions, Peritoneal,Intra Abdominal Infusions,Intra-Abdominal Infusion,Intraperitoneal Infusion,Parenteral Infusion,Peritoneal Infusion
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
D004349 Drug Packaging Containers, packaging, and packaging materials for drugs and BIOLOGICAL PRODUCTS. These include those in ampule, capsule, tablet, solution or other forms. Packaging includes immediate-containers, secondary-containers, and cartons. In the United States, such packaging is controlled under the Federal Food, Drug, and Cosmetic Act which also stipulates requirements for tamper-resistance and child-resistance. Similar laws govern use elsewhere. (From Code of Federal Regulations, 21 CFR 1 Section 210, 1993) DRUG LABELING is also available. Drug Containers and Closures,Packaging, Drug,Drug Containers,Container, Drug,Containers, Drug,Drug Container,Drug Packagings,Packagings, Drug
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
D006863 Hydrogen-Ion Concentration The normality of a solution with respect to HYDROGEN ions; H+. It is related to acidity measurements in most cases by pH pH,Concentration, Hydrogen-Ion,Concentrations, Hydrogen-Ion,Hydrogen Ion Concentration,Hydrogen-Ion Concentrations
D006868 Hydrolysis The process of cleaving a chemical compound by the addition of a molecule of water.
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
D013997 Time Factors Elements of limited time intervals, contributing to particular results or situations. Time Series,Factor, Time,Time Factor

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