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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 in refrigerator. Shake well before use.
Storage Conditions/Stability — Refrigerate. Stable for 90 days.
Study Container Type — Low-actinic, light-resistant prescription bottle
Referenced Manufacturer — Ursodiol powder, SyrSpend SF PH4 (Fagron).
Stability-Indicating Study — Yes
Polonini H, da Silva SL, Brandão MAF, et al.Compatibility of baclofen, carvedilol, hydrochlorothiazide, mercaptopurine, methadone hydrochloride, oseltamivir phosphate, phenobarbital, propranolol hydrochloride, pyrazinamide, sotalol hydrochloride, spironolactone, tacrolimus monohydrate, ursodeoxycholic acid, and vancomycin hydrochloride oral suspensions compounded with SyrSpend SF pH4. Int J Pharm Compd. 2018;22(6):516–526.
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