Atenolol Compounded Oral Solution

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Atenolol Compounded Oral Solution

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  1. DEFINITION
  2. ADDITIONAL REQUIREMENTS

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Atenolol Compounded Oral Solution contains NLT 90.0% and NMT 110.0% of the labeled amount of atenolol (C14H22N2O3).

Prepare Atenolol Compounded Oral Solution at a 2-mg/mL concentration, for example, as follows (see Pharmaceutical Compounding—Nonsterile Preparations 〈795〉)

Atenolol200 mg
Glycerin5 mL
Vehicle for Oral Suspension45 mL
Vehicle for Oral Solution, Sugar Free, a sucient quantity to make 100 mL

Calculate the quantity of each ingredient required for the total volume and atenolol strength to be prepared. Mix the Atenolol, previously pulverized, and Glycerin to form a smooth paste. Incorporate the Vehicle for Oral Suspension or an equal volume of Vehicle for Oral Solution, Sugar Free [NOTE-The Vehicle for Oral Suspension may be omitted.) Incorporate sufficient Vehicle for Oral Solution, Sugar Free in increments to bring to volume, and mix well. [NOTE-Do not use a sucrose-containing vehicle for oral solution.] Package, and label.

2 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Package in amber, tight containers, and store at controlled room temperature.

BEYOND-USE DATE: NMT 60 days after the day on which it was compounded when stored at controlled room temperature

LABELING: Label it to state that it is to be shaken well before use, and to state the Beyond-Use Date.

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