Vehicle for Oral Solution, Sugar Free
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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, 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 Purified Water to about 70°-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.
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 sugar-free oral solutions and suspensions.
Change to read:
BEYOND-USE DATE: NMT 6 months after preparation. ▲▲(CN 1-Nov-2023)
