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.
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 the solution 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 at room temperature or refrigerate. Shake well before use.
Storage Conditions/Stability — Store at room temperature or refrigerate. Stable for 28 days when refrigerated and 7 days when stored at room temperature.
STABILITY STUDY DETAILS:
Study Container Type — High-density polyethylene bottle with polypropylene cap
Referenced Manufacturer — Morphine hydrochloride powder (Taiwan Food and Drug Administration); sterile water for irrigation (not specified).
Stability-Indicating Study — No
Commercially available as a 2-, 4-, and 20-mg/mL solution as the sulfate salt — Use extemporaneously prepared formulation only when commercial product is unavailable or a more dilute solution is desired.
LinCY, ShenLJ, HuangCF, et al.Beyond-use date of extemporaneous morphine hydrochloride oral solution. Journal of Food and Drug Analysis. 2013;21:142–146.