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Containment ventilated enclosure (CVE) or biological safety cabinet (BSC), glass mortar and pestle, graduated cylinder
Caution: Hazardous Drug—Non-antineoplastic hazardous drug: Must be prepared in compliance with USP <800>.
Triturate tablets to a fine powder with a mortar and pestle.
Levigate powder with purified water 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: hazardous drug. 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 28 days.
Study Container Type — Amber type III glass prescription bottle with child-resistant closure
Referenced Manufacturers — Spironolactone tablets (G.D. Searle & Co); purified water USP (not specified); cherry syrup NF (Barre Drug Co, Inc).
Stability-Indicating Study — Yes
Commercially available as a 5-mg/mL suspension — Use extemporaneously prepared formulation only when commercial product is unavailable or a more concentrated syrup is desired.
Mathur LK, Wickman A. Stability of extemporaneously compounded spironolactone suspensions. Am J Hosp Pharm. 1989;46(10):2040–2042.
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