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1334893 
Technical Report 
Stability of octreotide acetate prefilled in plastic syringes 
Stiles, ML; Allen, LV; Resztak, KE; Prince, SJ 
1993 
IPA/93/1026154 
VOL 50 ISS Jun 1993 
REF 
eng 
IPA COPYRIGHT: ASHP It was the purpose of this study to determine the stability of octreotide acetate, prefilled in 3 ml plastic syringes, when stored at refrigerated (3DGC) and room (23DGC) temperatures and exposed to and protected from light. Three syringes were prepared for each sample period, for all four storage conditions, using undiluted drug (0.2 mg/ml). Sampling times were initially (d0), and day 8, day 15, day 22, and day 29. Following aseptic filling, the syringe tips were capped and the syringes placed in clear (light-exposed) and amber (light-resistant) plastic bags, along with 5 ml glass ampuls of drug (to be used as a control). At the designated sampling times three 1 ml samples were withdrawn from the drug ampuls. Along with the ampul samples, the syringe contents were expelled into 4 ml glass sample vials with screw-top caps. The sample vials were immediately stored at -20DGC until time of analysis. The drug stability was determined using high-performance liquid chromatography (HPLC). Plasticizer extractable determinations were made using gas chromatography (GC), initially and at the time of final sampling. A reference standard of diethylhexylphthalate (DEHP) in methylene chloride was used to prepare a standard curve. Although the syringe contents did show some variability, the results of the study indicated that, under all conditions, at least 90% of the drug remained after the designated time periods. 
Octreotide acetate; stability; photodecomposition; ASHP meeting abstracts; octreotide; Syringes; plastics; octreotide stability; Temperature; octreotide; stability; Photodecomposition; plastic syringes; Storage; stability; Practice Interest Areas; Home Health Care; meeting presentations