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INGREDIENTS:

Sodium benzoate powder50 g
Sterile water for irrigation100 mL
Ora-SweetQSAD: 200 mL

EQUIPMENT AND SUPPLIES:

Powder containment hood, pharmaceutical analytical scale, beaker, magnetic stirrer, filter, graduated cylinder

PREPARATION DETAILS:

  1. Weigh out powder and add to beaker.

  2. Add 100 mL of sterile water for irrigation and place the beaker on a magnetic stirrer.

  3. Stir the contents in the beaker thoroughly until dissolved.

  4. Filter solution into a graduated cylinder.

  5. Add vehicle to the graduated cylinder to achieve the total volume indicated above.

  6. Transfer contents of the graduated cylinder into an appropriately sized amber bottle.

  7. Shake well to mix.

Alternatives — May substitute vehicle with cherry syrup. Cherry syrup is prepared by mixing 1 mL of cherry flavoring with 999 mL of simple syrup NF.

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.

STABILITY STUDY DETAILS:

Study Container Type — Amber oval prescription vial with child-resistant closure

Referenced Manufacturers — Sodium benzoate powder (Sigma-Aldrich); Ora-Sweet (Perrigo Co); sterile water for irrigation, cherry flavoring, simple syrup (not specified).

Stability-Indicating Study — Yes

REFERENCE

1.

Atkins JR, Lull ME, Decker AS, et al.Stability of extemporaneously prepared sodium benzoate oral suspensions. Int J Pharm Compd. 2018;22:326328.

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