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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.
Division of Pharmacy, The University of Texas, M.D. Anderson Cancer Center, Houston, TX.
This article was published in the following journal.
Name: International journal of pharmaceutical compounding
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A multicenter, 12-month, open-label, single-arm safety study of oxycodone-hydrochloride/naltrexone-hydrochloride extended-release capsules (ALO-02) in patients with moderate-to-severe chronic noncancer pain.
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The thermal stability of the G-quadruplex formed from the thrombin-binding aptamer, 5'G2T2G2TGTG2T2G2, in which the guanine (G) base at the central loop was replaced with an adenine (A) or inosine (I)...
A fast and selective capillary electrophoresis method was developed and validated for the simultaneous determination of the hydrochloride and acetic acid content in prasugrel hydrochloride. Because of...
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Ph...
Osteopenia and osteoporosis cause thinning of bone tissue and loss of bone density over time. The purpose of this study is to determine the safety and effectiveness of nitroglycerin ointme...
Various mixtures of fats, waxes, animal and plant oils and solid and liquid hydrocarbons; vehicles for medicinal substances intended for external application; there are four classes: hydrocarbon base, absorption base, water-removable base and water-soluble base; several are also emollients.
A vesicant and necrotizing irritant destructive to mucous membranes. It was formerly used as a war gas. The hydrochloride is used as an antineoplastic in Hodgkin's disease and lymphomas. It causes severe gastrointestinal and bone marrow damage.
A mixture of liquid hydrocarbons obtained from petroleum. It is used as laxative, lubricant, ointment base, and emollient.
A colloidal system of semisolid hydrocarbons obtained from PETROLEUM. It is used as an ointment base, topical protectant, and lubricant.
Non-ionic surfactant of the polyethylene glycol family. It is used as a solubilizer and emulsifying agent in foods, cosmetics, and pharmaceuticals, often as an ointment base, and also as a research tool.
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