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Containment ventilated enclosure (CVE) or biological safety cabinet (BSC), mortar and pestle, graduated cylinder
Caution: Hazardous Drug—Antineoplastic drug: Must be prepared in compliance with USP <800>.
Open capsules and empty contents into a mortar.
Triturate contents to a fine powder.
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.
Special Instructions — *Mix 60 mL of Ora-Plus with 60 mL of Ora-Sweet. Use mixture as vehicle or use Ora-Blend.
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: antineoplastic 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 60 days.
Study Container Type — Amber plastic (polyethylene terephthalate [PET]) prescription oval with child-resistant cap
Referenced Manufacturers — Sunitinib malate capsules (Toronto Research Chemicals, Inc); Ora-Plus, Ora-Sweet (Paddock Laboratories, LLC).
Stability-Indicating Study — No
Navid F, Christensen R, Minkin P, et al.Stability of sunitinib in oral suspension. Ann Pharmacother. 2008;42(7):962–966.
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