Atenolol Oral Solution
DEFINITION
Atenolol Oral Solution contains NLT 90.0% and NMT 110.0% of the labeled amount of C14H22N2O3.
Prepare Atenolol Oral Solution at a 0.2% concentration, for example, as follows (see Pharmaceutical Compounding—Nonsterile Preparations 795).
Atenolol 200 mg
Glycerin 5 mL
Vehicle for Oral Suspension 45 mL
Vehicle for Oral Solution, Sugar Free,
a sufficient 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.
ADDITIONAL REQUIREMENTS
•  Packaging and Storage: Package in amber, tight containers, and store at controlled room temperature.
•  Labeling: Label it to state that it is to be shaken well before use, and discarded after 60 days. Label it to state that it is to be kept out of reach of children. Label it to indicate the nominal atenolol concentration.
•  Beyond-Use Date: NMT 60 days after the day on which it was compounded
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Jeanne H. Sun
Assistant Scientific Liaison
1-301-816-3361
(CMP2010) Compounding
USP35–NF30 Page 2261
Pharmacopeial Forum: Volume No. 29(4) Page 1001