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Laminar flow hood, 1 × 18-G needle, 1 × 3-mL syringe, 1 × 0.22-µm filter needle
Must be prepared in compliance with USP <797>.
Withdraw volume of injectable solution using a 3-mL syringe.
Change to a 0.22-µm filter needle.
Add injectable solution into the gentamicin ophthalmic 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 ophthalmic use only. Store in refrigerator.
Storage Conditions/Stability — Refrigerate. Stable for 90 days.
Study Container Type — Sterile plastic dropper bottle identical to that used for commercial gentamicin ophthalmic solution
Referenced Manufacturers — Gentamicin ophthalmic solution (Allergan, Inc); gentamicin sulfate injection (Lyphomed, Inc).
Stability-Indicating Study — No
Commercially available as a 0.3% (3 mg/mL) ophthalmic solution — Use extemporaneously prepared formulation only when a more concentrated ophthalmic solution is desired.
McBride HA, Martinez DR, Trang JM, et al.Stability of gentamicin sulfate and tobramycin sulfate in extemporaneously prepared ophthalmic solutions at 8°C. Am J Hosp Pharm. 1991;48(3):507–509.
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