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Powder containment hood, mortar and pestle, graduated cylinder
Triturate tablets 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.
Special Instructions — *Mix 80 mL of Ora-Plus with 80 mL of Ora-Sweet SF. Use mixture as vehicle or use Ora-Blend SF.
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. For oral use only. Store at room temperature. Use within 30 days after first opening. Shake well before use.
Storage Conditions/Stability — Store at room temperature. Stable for 100 days.
Study Container Type — Amber polyethylene terephthalate (PET) bottle
Referenced Manufacturers — Candesartan cilexetil tablets (Atacand, AstraZeneca); Ora-Plus, Ora-Sweet SF, Ora-Blend SF (Paddock Laboratories, LLC).
Stability-Indicating Study — No
Atacand [prescribing information]. Wilmington, DE: AstraZeneca; 2016.
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