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Containment ventilated enclosure (CVE) or biological safety cabinet (BSC), mortar and pestle, graduated cylinder
Caution: Hazardous Drug—Reproductive hazards: Must be prepared in compliance with USP <800>.
Open capsules and empty contents into a mortar.
Triturate contents to a fine powder.
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 60 mL of Ora-Plus with 60 mL of Ora-Sweet. Use mixture as vehicle or use Ora-Blend.
Alternatives — May substitute vehicle with 11 mL methylcellulose 1% (see page 107 for preparation directions) mixed with 109 mL 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. Caution: reproductive hazards. 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 91 days.
Study Container Type — Plastic bottle
Referenced Manufacturer — Not specified
Stability-Indicating Study — Yes
Nahata MC. Long-term stability of zonisamide, amitriptyline, and glycopyrrolate in extemporaneously prepared liquid-dosage form at two temperatures. Int J Pharm Compd. 2016;20(2):164–166.
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