General Chapter <795> Pharmaceutical Compounding—Nonsterile Preparations. In: United States Pharmacopeia and National Formulary (USP 43-NF 38). Revised January 1, 2014. Rockville, MD: The United States Pharmacopeia Convention Inc; 2020.
Containment ventilated enclosure (CVE) or biological safety cabinet (BSC), pharmaceutical analytical scale, mortar and pestle, graduated cylinder
Caution: Hazardous Drug—Non-antineoplastic hazardous drug: Must be prepared in compliance with USP <800>.
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. Caution: hazardous 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 90 days.
STABILITY STUDY DETAILS:
Study Container Type — Low-actinic, light-resistant prescription bottle
Referenced Manufacturer — Propylthiouracil powder, SyrSpend SF PH4 (Fagron).
Stability-Indicating Study — Yes
FerreiraAO, PoloniniH, da SilvaSL, et al.Stability of acetazolamide, baclofen, dipyridamole, mebeverine hydrochloride, propylthiouracil, quinidine sulfate, and topiramate oral suspensions in SyrSpend SF PH4. Int J Pharm Compd. 2017;21(4):339–346.
FerreiraAO, PoloniniH, da SilvaSL, et al.Stability of acetazolamide, baclofen, dipyridamole, mebeverine hydrochloride, propylthiouracil, quinidine sulfate, and topiramate oral suspensions in SyrSpend SF PH4. Int J Pharm Compd. 2017;21(4):339–346.)| false