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Powder containment hood, 1 × 18-G needle, 1 × 60-mL syringe, graduated cylinder
Withdraw volume of injectable solution using a 60-mL syringe.
Transfer solution to a 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.
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.
Study Container Type — Amber glass bottle with child-resistant closure
Referenced Manufacturers — Midazolam hydrochloride injection (Versed, Hoffman-La Roche); Syrpalta (Emerson Laboratories).
Stability-Indicating Study — Yes
Commercially available as a 2-mg/mL syrup — Use extemporaneously prepared formulation only when commercial product is unavailable or a more concentrated syrup is desired.
Steedman SL, Koonce JR, Wynn JE, et al.Stability of midazolam hydrochloride in a flavored, dye-free oral solution. Am J Hosp Pharm. 1992;49:615–618.
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