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
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 50 mL of Ora-Plus with 50 mL of Ora-Sweet SF. Use mixture as vehicle or use Ora-Blend SF.
Alternatives — May substitute vehicle with 50 mL of Ora-Plus mixed with 50 mL of Ora-Sweet or Ora-Blend. Stable for 1 day when refrigerated.
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 2 days.
STABILITY STUDY DETAILS:
Study Container Type — Amber clear polyethylene terephthalate (PET) prescription ovals with low-density polyethylene foam cap linings
Referenced Manufacturers — Hydralazine hydrochloride tablets (Rugby Laboratories, Inc); Ora Plus, Ora-Sweet, Ora-Sweet SF (Paddock Laboratories, LLC).
Stability-Indicating Study — Yes
AllenLVJr, EricksonMA 3rd. Stability of alprazolam, chloroquine phosphate, cisapride, enalapril maleate, and hydralazine hydrochloride in extemporaneously compounded oral liquids. Am J Health Syst Pharm. 1998;55(18):1915–1920.