Assessing the stability of common radiopharmaceuticals compounded and utilized outside package insert guidelines
- PMID: 24046939
Assessing the stability of common radiopharmaceuticals compounded and utilized outside package insert guidelines
Abstract
The objective of this study was to evaluate the stability of radiopharmaceuticals compounded using activities and expiration times in excess of manufacturers' recommendations. Proof of the compounded sterile preparation quality when compounding outside of manufacturers' recommendations has become a key component of maintaining compliance with the guidelines set forth in United States Pharmacopeia General Chapter <797> Pharmaceutical Compounding-Sterile Preparations, originally released in 2008. Seven commercial nuclear pharmacies compounded various radiopharmaceuticals for patient use as part of daily pharmacy protocol. Samples of radiopharmaceuticals were tested using instant thin- layer chromatography testing to determine the radiochemical purity of the final compounded sterile preparation at t = 0, t = 6, t = 12, and t = 24 hours post compounding. Data submitted was summarized and divided into activity ranges allowing for calculation of average radiochemical purity for various activity levels at each of the four time points. Data was presented in graph form showing the average radiochemical purity values versus time with inclusion of error bars to indicate standard deviation data. The stability of each kit at different activity levels and at different time points post compounding showed that many of the radiopharmaceutical kits prepared today may have an unacceptable decrease in radiochemical purity at higher activity levels and at extended times post compounding. The data submitted provides a general guideline for the stability of radiopharmaceuticals compounded outside of manufacturer guidelines and can be used as a tool to support the practices that are being carried out at individual institutions. However, this data should be used in conjunction with in-house data review to assure that the preparations being compounded and dispensed are of the highest quality for administration to the patient.
Similar articles
- Establishing benchmark rates of microbial and bacterial endotoxin contamination for radiopharmaceuticals compounded in commercial nuclear pharmacy settings.Int J Pharm Compd. 2013 Mar-Apr;17(2):168-74. Int J Pharm Compd. 2013. PMID: 23696179
- Deficiencies of product labeling directions for the preparation of radiopharmaceuticals.J Am Pharm Assoc (2003). 2004 Jan-Feb;44(1):30-5. doi: 10.1331/154434504322713200. J Am Pharm Assoc (2003). 2004. PMID: 14965150
- Influence of Storage Temperature on Radiochemical Purity of 99mTc-Radiopharmaceuticals.Molecules. 2018 Mar 15;23(3):661. doi: 10.3390/molecules23030661. Molecules. 2018. PMID: 29543722 Free PMC article.
- Basics of compounding: considerations for implementing United States pharmacopeia chapter 797 pharmaceutical compounding-sterile preparations, part 4: considerations in selection and use of disinfectants and antiseptics.Int J Pharm Compd. 2007 Nov-Dec;11(6):492-9. Int J Pharm Compd. 2007. PMID: 23994811
- USP General Chapter <825> Impact on Nuclear Medicine Technology Practice.J Nucl Med Technol. 2020 Jun;48(2):106-113. doi: 10.2967/jnmt.120.243378. J Nucl Med Technol. 2020. PMID: 32499321 Review.
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources