U.S. PHARMACOPEIA

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Vehicle for Oral Solution, Sugar Free
» Prepare Vehicle for Oral Solution, Sugar Free as follows (see Pharmaceutical Compounding—Nonsterile Preparations 795).
Xanthan Gum 50 mg
Glycerin 10 mL
Sorbitol Solution 25 mL
Saccharin Sodium 100 mg
Citric Acid Monohydrate 1.5 g
Sodium Citrate 2 g
Methylparaben 100 mg
Potassium Sorbate 100 mg
Purified Water, a sufficient quantity
to make		 100 mL
Calculate the quantity of each ingredient required for the total amount to be prepared. Accurately weigh/measure each ingredient. Heat about 60 mL of water to about 70 to 75. Add the Methylparaben, and stir until dissolved. Remove from the heat, and add the Glycerin, Sorbitol Solution, Saccharin Sodium, Citric Acid Monohydrate, Sodium Citrate, Potassium Sorbate, and Xanthan Gum. Add sufficient Purified Water to volume, and mix well. Adjust the pH if necessary. Package, and label.
Packaging and storage— Package in a tight, light-resistant container, and store at controlled room temperature.
Labeling— Label it to indicate that it is for use in compounding sugar-free oral solutions and suspensions.
pH 791: an apparent pH between 4.0 and 5.0.
Beyond-use date: not more than 6 months after preparation. A beyond-use date of more than 6 months may be assigned if supporting stability data exist. (See Stability Criteria and Beyond-Use Dating under Pharmaceutical Compounding—Nonsterile Preparations 795.)
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Auxiliary Information— Staff Liaison : Claudia C. Okeke, Ph.D., Associate Director
Expert Committee : (CRX05) Compounding Pharmacy05
USP29–NF24 Page 3456
Pharmacopeial Forum : Volume No. 29(4) Page 1115
Phone Number : 1-301-816-8243