Vehicle for Oral Solution, Sugar Free
» Prepare Vehicle for Oral Solution, Sugar Free as follows (see Pharmaceutical Compounding—Nonsterile Preparations 
795
).
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.
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.
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 | Rick G. Schnatz
Manager, Compounding Pharmacy Expert Committee 1-301-816-8526 |
(CRX05) Compounding Pharmacy05 |
USP32–NF27 Page 1292
Pharmacopeial Forum: Volume No. 29(4) Page 1115