Content area
Full Text
Rx
For 100 mL
Hydralazine hydrochloride 100 mg or 1 g
Sorbitol solution 70% 40 g
Methylparaben 65 mg
Propylparaben 35 mg
Propylene glycol 10g
Aspartame 50 mg
Purified water qs 100 mL
METHOD OF PREPARATION
1. Calculate the required quantity of each ingredient for the total amount to be prepared.
2. Accurately weigh and/or measure each ingredient.
3. Dissolve the parabens in the propylene glycol.
4. Dissolve the hydralazine in about 30 mL of purified water.
5. Add the aspartame and mix until dissolved.
6. Add the sorbitol solution and mix well.
7. Add sufficient purified water to volume and mix well.
8. Package and label.
PACKAGING
Package in tight, light-resistant containers.1
LABELING
Keep out of reach of children. Use only as directed.
STABILITY
A beyond-use date of 30 days stored in a refrigerator can be used for this preparation.
USE
Hydralazine oral liquid is used as a vasodilating agent in the treatment of hypertension and congestive heart failure.
QUALITY CONTROL
Quality-control assessment can include weight/volume, pH, specific gravity, active drug assay, color, clarity, rheological properties/pourability, physical observation, and physical stability (discoloration, foreign materials, gas formation, mold growth).'
DISCUSSION
Hydralazine hydrochloride is...