Stability and purity profile of gonadorelin acetate: a high-purity gonadotropin-releasing hormone.
Recently, several reports of adverse reactions after pulsatile GnRH (gonadorelin hydrochloride) infusion therapy have appeared in the medical literature. Although the cause of these reactions has been associated with GnRH itself, the contributions of impurities and degradation products in the administered drug have not been determined, suggesting that the use of high-purity material may be advantageous in controlling unwanted side effects. This study evaluates the purity and long-term stability of a new GnRH product, gonadorelin acetate (Lutrepulse, Ortho Pharmaceutical Corporation). Both the purity and potency of the drug substance, the lyophilized product for injection, and the reconstituted material that would be transferred to the infusion pump system were monitored using high-performance liquid chromatography. The gonadorelin acetate drug substance was found to be stable for at least 12 months when stored at 24 degrees C in 50% relative humidity, and showed no degradation even under accelerated storage conditions. Similarly, the lyophilized product also showed excellent stability for at least 18 months when stored at 24 degrees C in 50% relative humidity. Upon reconstitution, gonadorelin acetate was found to be stable for at least 45 days when stored at 24 degrees C or 37 degrees C.
Wong
W
W
R.W. Johnson Pharmaceutical Research Institute, Ortho Pharmaceutical Corporation, Raritan, New Jersey.
Mercorelli
M
M
DeLuccia
F
F
Young
R
R
Lane
P A
PA
Hoerig
J
J
Turan
A
A
D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D004356:Drug Storage; D007987:Gonadotropin-Releasing Hormone / Q000737:chemistry*
D007987:Gonadotropin-Releasing Hormone