Assessing the stability of common radiopharmaceuticals compounded and utilized outside package insert guidelines

Area of Science:

• Nuclear Pharmacy
• Radiopharmaceutical Compounding
• Pharmaceutical Quality Assurance

Background:

• United States Pharmacopeia (USP) General Chapter <797> provides guidelines for sterile compounding.
• Compounding radiopharmaceuticals outside manufacturer recommendations requires quality assessment.
• Ensuring the quality of compounded sterile preparations is crucial for patient safety.

Purpose of the Study:

• To assess the stability of radiopharmaceuticals prepared with higher-than-recommended activities and extended expiration times.
• To evaluate the impact of compounding parameters on radiochemical purity.
• To provide data supporting quality control for non-standard radiopharmaceutical preparations.

Main Methods:

• Seven nuclear pharmacies participated in the study.
• Radiopharmaceuticals were compounded for patient use following daily protocols.
• Instant thin-layer chromatography (ITLC) was used to determine radiochemical purity at 0, 6, 12, and 24 hours post-compounding.
• Data was analyzed based on activity levels and time points.

Main Results:

• Radiochemical purity was assessed at various time intervals post-compounding.
• Average radiochemical purity was calculated for different activity ranges and time points.
• Results indicated a potential decrease in radiochemical purity for some kits at higher activities and extended times.
• Data was presented graphically with error bars showing standard deviation.

Conclusions:

• Many radiopharmaceutical kits may exhibit unacceptable decreases in radiochemical purity when compounded outside manufacturer guidelines.
• The study provides a guideline for radiopharmaceutical stability under non-standard conditions.
• Institutions should use this data alongside in-house reviews to ensure preparation quality for patient administration.