Vehicle for Oral Solution,Sugar Free
»Prepare Vehicle for Oral Solution,Sugar Free as follows (see Pharmaceutical Compounding—Nonsterile Preparations á795ñ).
| Xanthan Gum | 50mg |
| Glycerin | 10mL |
| Sorbitol Solution | 25mL |
| Saccharin Sodium | 100mg |
| Citric Acid Monohydrate | 1.5g |
| Sodium Citrate | 2g |
| Methylparaben | 100mg |
| Potassium Sorbate | 100mg |
| Purified Water,a sufficient quantity to make |
100mL |
Calculate the quantity of each ingredient required for the total amount to be prepared.Accurately weigh/measure each ingredient.Heat about 60mLof 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 pHif 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 pHif 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.
pHá791ñ:
an apparent pHbetween 4.0and 5.0.
Beyond-use date:
not more than 6months after preparation.Abeyond-use date of more than 6months may be assigned if supporting stability data exist.(See Stability Criteria and Beyond-Use Datingunder Pharmaceutical Compounding—Nonsterile Preparations á795ñ.)
Auxiliary Information—
Staff Liaison:Claudia C.Okeke,Ph.D.,Associate Director
Expert Committee:(CRX)Compounding Pharmacy
USP28–NF23Page 3105
Pharmacopeial Forum:Volume No.29(4)Page 1115
Phone Number:1-301-816-8243