Vehicle for Oral Solution
»Prepare Vehicle for Oral Solution as follows (see Pharmaceutical Compounding—Nonsterile Preparations á795ñ).
| Sucrose | 80g |
| Glycerin | 5g |
| Sorbitol | 5g |
| Sodium Phosphate,Dibasic | 120mg |
| Citric Acid | 200mg |
| Potassium Sorbate | 100mg |
| Methylparaben | 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 30mLof 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 pHif 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 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 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 3104
Pharmacopeial Forum:Volume No.29(4)Page 1114
Phone Number:1-301-816-8243