Stability of mechlorethamine hydrochloride 0.01% ointment in aquaphor base. 1998

Y Zhang, and L A Trissel, and J F Johansen, and C L Kimball
Division of Pharmacy, The University of Texas, M.D. Anderson Cancer Center, Houston, TX.

The purpose of this project was to evaluate the short-term shelf-life stability of an extemporaneously compounded mechlorethamine hydrochloride 0.01% topical ointment stored at room temperature. Mechlorethamine hydrochloreide injection 10-mg vials were reconstituted with 1 mL of dehydrated alcohol injection, USP, yielding a 10-mg/mL solution. One milliliter of the reconstituted liquid was incorporated by spatulation into 100 g of Aquaphor ointment base, yielding an ointment containing mechlorethamine hydrochloride 0.01%. The ointment was packaged in screw-cap ointment jars and stored at 23 deg C. Chemical stability was evaluated over a 90 day-period using derivatization and a stability-indicating high-performance liquid chromatographic analytical method. Decomposition of the intact drug occurred at a mcuh slower rate than that observed in aqueous solutions. The loss appeared to be biphasic, occurring more rapidly during the first week and proceeding much more slowly thereafter. Mechlorethamine hydrochloride solubilized with dehydrated alcohol injection and incorporated into Aquaphor ointment base at a concentration of 0.01% lost 10% potency in seven days when stored at 23 deg C.

UI MeSH Term Description Entries

Related Publications

Y Zhang, and L A Trissel, and J F Johansen, and C L Kimball
July 1980, Archives of dermatology,
Y Zhang, and L A Trissel, and J F Johansen, and C L Kimball
January 1993, The Journal of pharmacy and pharmacology,
Y Zhang, and L A Trissel, and J F Johansen, and C L Kimball
January 1972, Journal of dental research,
Y Zhang, and L A Trissel, and J F Johansen, and C L Kimball
January 1974, Journal of pharmaceutical sciences,
Y Zhang, and L A Trissel, and J F Johansen, and C L Kimball
December 1983, Cancer,
Y Zhang, and L A Trissel, and J F Johansen, and C L Kimball
January 2016, International journal of pharmaceutical compounding,
Y Zhang, and L A Trissel, and J F Johansen, and C L Kimball
September 1985, Die Pharmazie,
Y Zhang, and L A Trissel, and J F Johansen, and C L Kimball
January 1982, Contact dermatitis,
Y Zhang, and L A Trissel, and J F Johansen, and C L Kimball
April 1982, Archives of dermatology,
Y Zhang, and L A Trissel, and J F Johansen, and C L Kimball
January 1985, Annales de dermatologie et de venereologie,
Copied contents to your clipboard!