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.
Add distilled water slowly while dissolution occurs.
Add sodium ascorbate injection to graduated cylinder.
Add remaining distilled water to graduated cylinder to achieve the total volume indicated above.
Transfer the solution into an appropriately sized amber bottle.
Shake well to mix.
Alternatives — May substitute additive with ascorbic acid 500 mg tablet, with stability of 56 days when refrigerated or 28 days when stored at room temperature. Formulation without sodium ascorbate injection or ascorbic acid tablet is stable for 14 days when refrigerated or 7 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 or refrigerate. Shake well before use.
Storage Conditions/Stability — Store at room temperature or refrigerate. Stable for 56 days when refrigerated and 14 days when stored at room temperature.
STABILITY STUDY DETAILS:
Study Container Type — Glass prescription bottle
Referenced Manufacturers — Captopril tablets (E.R. Squibb & Sons, LLC); distilled water (Magnetic Spring Bottled Water Co); sodium ascorbate injection (Eli Lilly & Co); ascorbic acid tablet (UDL Laboratories).
Stability-Indicating Study — Yes
NahataMC, MoroscoRS, HippleTF.Stability of captopril in three liquid dosage forms. Am J Hosp Pharm. 1994;51(1):95–96.
NahataMC, MoroscoRS, HippleTF.Stability of captopril in three liquid dosage forms. Am J Hosp Pharm. 1994;51(1):95–96.)| false