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Containment ventilated enclosure (CVE) or biological safety cabinet (BSC), pharmaceutical analytical scale, mortar and pestle, graduated cylinder
Caution: Hazardous Drug—Non-antineoplastic hazardous drug: Must be prepared in compliance with USP <800>.
Open capsules and empty contents into a mortar.
Weigh out citric acid powder and add to mortar and pestle.
Triturate contents to a fine powder.
Measure and add propylene glycol to the powder in the mortar.
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: hazardous drug. For oral use only. Store in refrigerator. Shake well before use.
Storage Conditions/Stability — Refrigerate. Stable for 7 days.
Study Container Type — Amber glass bottle with a tight-fitting cap
Referenced Manufacturers — Phenoxybenzamine hydrochloride capsules (Dibenzyline, Smith Kline & French Laboratories, Ltd); propylene glycol (Sino Chemicals); citric acid monohydrate powder (Merck & Co); distilled water (not specified).
Stability-Indicating Study — Yes
Lim LY, Tan LL, Chan EWY, et al.Stability of phenoxybenzamine hydrochloride in various vehicles. Am J Health Syst Pharm. 1997;54:2073–2078.
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