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Vehicle for Oral Solution
» Prepare Vehicle for Oral Solution as follows (see Pharmaceutical Compounding—Nonsterile Preparations 795).
Sucrose 80 g
Glycerin 5 g
Sorbitol 5 g
Sodium Phosphate, Dibasic 120 mg
Citric Acid 200 mg
Potassium Sorbate 100 mg
Methylparaben 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 30 mL of Purified Water to 70 to 75. Add the Glycerin and Methylparaben, and stir until the Methylparaben is dissolved. Add the Dibasic Sodium Phosphate, Citric Acid, Potassium Sorbate, and Sorbitol, and mix well. Add the Sucrose, and mix until dissolved; remove from the heat, and allow to cool. 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 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 3455
Pharmacopeial Forum : Volume No. 29(4) Page 1114
Phone Number : 1-301-816-8243