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Powder containment hood, glass mortar and pestle, graduated cylinder
Triturate tablets to a fine powder with a mortar and pestle.
Levigate powder with purified water 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.
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 in refrigerator. Shake well before use.
Storage Conditions/Stability — Refrigerate. Stable for 28 days.
Study Container Type — Amber type III glass prescription bottle with child-resistant closure
Referenced Manufacturers — Clonidine hydrochloride tablets (Catapres, Boehringer Ingelheim); purified water (not specified); simple syrup (Humco).
Stability-Indicating Study — Yes
Levinson ML, Johnson CE. Stability of an extemporaneously compounded clonidine hydrochloride oral liquid. Am J Hosp Pharm. 1992;49(1):122–125.
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