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Containment ventilated enclosure (CVE) or biological safety cabinet (BSC), mortar and pestle, graduated cylinder
Caution: Hazardous Drug—Reproductive hazards: Must be prepared in compliance with USP <800>.
Triturate tablet to a fine powder with a mortar and pestle.
Levigate powder with a small amount of vehicle to form a paste.
Add vehicle in increasing amounts while mixing thoroughly.
Transfer contents of the mortar to a graduated cylinder.
Rinse the mortar and pestle with vehicle and pour into graduated cylinder.
Add vehicle to the graduated cylinder to achieve the total volume indicated above.
Transfer contents of the graduated cylinder into an appropriately sized amber bottle.
Shake well to mix.
Quality-Control Procedures — Visually inspect for physical appearance of formulation and container closure integrity (no leakage, cracks in container, or improper seals).
Labeling Requirements — Extemporaneously compounded preparation. Caution: reproductive hazards. For oral use only. Store at room temperature or refrigerate. Shake well before use.
Storage Conditions/Stability — Store at room temperature or refrigerate. Stable for 15 days.
Study Container Type — Borosilicate glass vial with Teflon septa
Referenced Manufacturer — Fluconazole tablet (Diflucan, Pfizer); deionized water (not specified).
Stability-Indicating Study — Yes
Commercially available as a 10- and 40-mg/mL suspension — Use extemporaneously prepared formulation only when commercial product is unavailable or a more dilute solution is desired.
Yamreudeewong W, Lopez-Anaya A, Rappaport H. Stability of fluconazole in an extemporaneously prepared oral liquid. Am J Hosp Pharm. 1993;50:2366–2367.
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