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.
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 xanthan gum 0.25 g, glycerin 10 mL, and parabens concentrate 1 mL in simple syrup USP 50 mL and a sufficient amount of purified water to make 100 mL. Use mixture as vehicle.
Alternatives — May substitute vehicle with sodium carboxymethylcellulose 0.1 g, glycerin 5 mL, sorbitol solution 20 mL, and parabens concentrate 1 mL in simple syrup USP 50 mL and a sufficient amount of purified water to make 100 mL.
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. Protect from light. Shake well before use.
Storage Conditions/Stability — Store at room temperature or refrigerate. Protect from light. Stable for 60 days.