Table 5. Comparison of studies evaluating the quality of compounded 17-OHPC.

Chollet and Jozwiakowsk (October 2011)	FDA Report (June 2012)	Current Study
ACTIVE PHARMACEUTICAL INGREDIENT (Hydroxyprogesterone caproate powder)
10 samples evaluated	16 samples evaluated	Not done
1/10 samples OOSL for content (HPLC)	0/16 samples OOSL for potency	Not done
8/9 samples OOSL for unspecified impurities	0/16 samples OOSL for total purity, 16/16 OOSL for unidentified impurities, 4 impurities identified	Not done
COMPOUNDED FORMULATIONS OF 17-OHPC
30 samples from 30 compounding pharmacies	26 ″retained samples from C&J tests and 13 FDA samples from 8 compounding pharmacies	18 samples from 15 compounding pharmacies
5/30 samples OOSL for content (HPLC)	3/26 of C&J samples OOSL for potency	0/18 samples OOSL for content
17/30 samples OOSL for unspecified impurities	7/26 C&J samples OOSL for impurities	1/18 OOSL for impurities
	1/13 FDA-acquired samples OOSL for potency
	0/13 FDA-acquired samples OOSL for total impurities but 2/13 samples OOSL for unidentified impurities stds for impurities)
STERILITY & ENDOTOXIN TESTING OF COMPOUNDED FORMULATIONS
Sterility testing not reported	Sterility testing not reported	18/18 samples passed sterility testing
Pyrogen testing not reported	Pyrogen testing not reported	16/16 samples passed pyrogen testing

OOSL= Out of specification limit

C&J= Chollet and Jozwiakowsk