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.
Powder containment hood, mortar and pestle, graduated cylinder
Open capsules and empty contents into 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 Oral Mix SF or 60 mL of Ora-Plus mixed with 60 mL of Ora-Sweet, or Ora-Blend. Stable for 56 days when stored at room temperature. Also may substitute using 60 mL of methylcellulose 1% (see page 107 for preparation directions) mixed with 60 mL of simple syrup NF. Stable for 56 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 at room temperature. Shake well before use.
Storage Conditions/Stability — Store at room temperature. Stable for 90 days.
Note: Because precipitation was observed at 5°C for all vehicles, these preparations should NOT be refrigerated.1
STABILITY STUDY DETAILS:
Study Container Type — Amber polyethylene terephthalate (PET) bottle with black phenolic cap and 1-mL amber oral syringe1; amber plastic prescription bottle2