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Accuracy of testosterone concentrations in compounded testosterone products.
Ethan D Grober1, Alaina Garbens1, Andrea Božović2,3
1Department of Surgery, Division of Urology, Mount Sinai and Women's College Hospital, Toronto, Ontario, Canada.
Compounded testosterone products show significant variability in actual testosterone concentrations, potentially impacting treatment effectiveness and safety. Many pharmacies failed to meet accuracy standards compared to commercial preparations.
Area of Science:
- Endocrinology
- Pharmaceutical Sciences
- Analytical Chemistry
Background:
- Compounded medications are increasingly used for hormone replacement therapy.
- Accurate dosing is critical for the efficacy and safety of testosterone replacement therapy.
Purpose of the Study:
- To assess the accuracy of testosterone concentrations in compounded gels and creams.
- To compare the variability of compounded testosterone products with commercially available formulations.
Main Methods:
- Ten compounding pharmacies in Toronto participated in a blinded study.
- Standardized prescriptions for compounded testosterone were submitted, with two batches analyzed per pharmacy.
- Testosterone concentrations were measured using liquid chromatography-tandem mass spectrometry.
- Commercial products (Androgel, Testim) served as accuracy controls.
Main Results:
- Significant variability in testosterone concentrations was observed within and between compounding pharmacies.
- Only 50% (batch 1) and 30% (batch 2) of compounded products met the ±20% accuracy threshold.
- Two pharmacies exceeded the 20% deviation, and one provided a product with negligible testosterone.
- Commercial testosterone products demonstrated consistent and accurate concentrations.
Conclusions:
- Compounded testosterone products exhibit unreliable testosterone concentrations.
- Variability in compounded testosterone may compromise therapeutic outcomes and patient safety.
- This highlights the need for rigorous quality control in compounding pharmacies.
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