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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.
Alternatives — May substitute vehicle with SyrSpend SF PH4, cherry flavored. Stable for 154 days when stored at room temperature.
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 in refrigerator. Shake well before use.
Storage Conditions/Stability — Refrigerate. Stable for 90 days.
Study Container Type — Low-actinic, light-resistant prescription bottle
Referenced Manufacturers — Phenobarbital powder, SyrSpend SF PH4 (Fagron).1 Phenobarbital powder (Sigma-Aldrich); SyrSpend SF PH4, cherry flavored (Fagron).2
Stability-Indicating Study — Yes
Commercially available as a 4-mg/mL elixir and solution — Use extemporaneously prepared formulation only when commercial product is unavailable or a more concentrated suspension is desired.
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Geiger CM, Sorenson B, Whaley P. Stability assessment of 10 active pharmaceutical ingredients compounded in SyrSpend SF. Int J Pharm Compd. 2015;19:420–427.
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