Vehicle for Oral Solution
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Tóm tắt nội dung
This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
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°-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.
2 SPECIFIC TESTS
pH (791): An apparent pH between 4.0 and 5.0
3 ADDITIONAL REQUIREMENTS
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.
Change to read:
BEYOND-USE DATE: NMT 6 months after preparation.▲▲(CN 1-Nov-2023)
