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Powder containment hood, pharmaceutical analytical scale, mortar and pestle, graduated cylinder
Weigh out powder and add to 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.
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 or refrigerate. Shake well before use.
Storage Conditions/Stability — Store at room temperature or refrigerate. Stable for 91 days.
Study Container Type — Low-actinic plastic prescription bottle
Referenced Manufacturers — Amiodarone hydrochloride powder (Sigma-Aldrich); SyrSpend SF PH4, cherry flavored (Fagron).
Stability-Indicating Study — Yes
Geiger CM, Sorenson B, Whaley P. Stability assessment of 10 active pharmaceutical ingredients compounded in SyrSpend SF. Int J Pharm Compd. 2015;19(5):420-427.
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