| Stability of fentanyl 5 microg/mL diluted with 0.9% sodium chloride injection and stored in polypropylene syringes. | |
| | |
MedLine Citation:
|
PMID: 19386950 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
PURPOSE: The stability of fentanyl 5 microg/mL in 0.9% sodium chloride solution packaged in polypropylene syringes was studied. METHODS: Samples of fentanyl 5 microg (as the citrate) per milliliter in 0.9% sodium chloride injection were prepared and assessed for chemical stability using a validated, stability-indicating high- performance liquid chromatographic (HPLC) assay. A total of 12 syringe samples were submitted for chemical stability testing by HPLC. The syringes were protected from light and stored in controlled ambient conditions (23-27 degrees C and 55-65% relative humidity) in an environmental chamber. Three samples were tested initially and at each 30-day interval. Each syringe sample was tested with two determinations, using the average of the determinations for the assay result. Samples were assessed for pH and inspected for color and visible particulate matter. Stability was defined as the retention of 90-110% of the initial drug concentration at 30, 60, and 90 days. RESULTS: Fentanyl citrate injection maintained the appearance of a clear, colorless solution, with mean +/- S.D. pH values ranging from 4.13 +/- 0.01 to 4.52 +/- 0.02 throughout the study period. Recovery of fentanyl ranged from 99.86% +/- 0.29% to 102.74% +/- 1.60% of the initial concentration, with no detectable changes in the chromatographic profiles of all tested samples. CONCLUSION: Fentanyl 5 microg (as the citrate) per milliliter in 0.9% sodium chloride injection, packaged in polypropylene syringes and stored protected from light, was stable for at least 90 days in controlled ambient conditions. |
| | |
Authors:
|
Susan V McCluskey; Kevin K Graner; Jesse Kemp; Vasileios Aloumanis; Michel Ben; Thomas Kupiec; Nicole Vu |
Publication Detail:
|
Type: Comparative Study; Journal Article |
Journal Detail:
|
Title: American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists Volume: 66 ISSN: 1535-2900 ISO Abbreviation: Am J Health Syst Pharm Publication Date: 2009 May |
Date Detail:
|
Created Date: 2009-04-23 Completed Date: 2009-07-20 Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 9503023 Medline TA: Am J Health Syst Pharm Country: United States |
Other Details:
|
Languages: eng Pagination: 860-3 Citation Subset: IM |
Affiliation:
|
Mayo Clinic Rochester, Rochester, MN 55902, USA. mccluskey.susan@mayo.edu |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Drug Stability Fentanyl / administration & dosage, chemistry* Pharmaceutical Solutions / administration & dosage, chemistry Polypropylenes* / standards Sodium Chloride / administration & dosage, chemistry* Syringes* / standards |
| Chemical | |
Reg. No./Substance:
|
0/Pharmaceutical Solutions; 0/Polypropylenes; 437-38-7/Fentanyl; 7647-14-5/Sodium Chloride |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Effects of an integrated medicines management program on medication appropriateness in hospitalized ...
Next Document: Klippel-Trenaunay syndrome with hemimegalencephaly, retroperitoneal lymphangioma and double inferior...