Objectives 17-hydroxyprogesterone caproate (17-OHPC) is available both as an FDA – approved medication and as a product prepared for individual patients by compounding pharmacies. Compounding pharmacies may omit the preservative used in the FDA approved formulation or use an alternate preservative and may dispense 17-OHPC in containers that differ from the FDA-approved product. The objective of this study was to assess the stability, microbiological and pyrogen status of 17-OHPC formulations under various compounding and dispensing conditions. Methods 17-OHPC was prepared by a local compounding pharmacy. The formulations prepared included one identical to the FDA approved product with benzyl alcohol as a preservative, one with benzalkonium chloride as a preservative and one without a preservative. These various formulations were dispensed into either single dose 1 ml plastic syringes or glass vials or 10 ml glass vials. Concentration of 17-OHPC and microbial and pyrogen status were evaluated at various time intervals over the ensuing 19 weeks. Results The concentration of 17-OHPC did not change over the duration of study regardless of the dispensing medium used or the absence or presence of any preservatives. The preparations remained microbe and pyrogen free during the study period regardless of the dispensing medium used or the absence of presence of any preservatives. Conclusions Products containing 17-OPHC tested in this study were quite stable over the 19-week period of study in different dispensing containers and in absence or presence of a different preservative. The compounded products remained sterile and pyrogen free during the period of observation.

Hydroxyprogesterone caproate in powder form and in a pharmaceutical formulation under different experimental conditions appeared to be fairly stable in the presence of strong acid, high temperatures, and light.

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