Vehicle for Oral Solution
» Prepare Vehicle for Oral Solution as follows (see Pharmaceutical Compounding—Nonsterile Preparations 
795
).
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.
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.
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.)
795.)
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 1880
Pharmacopeial Forum: Volume No. 29(4) Page 1114