Hydralazine Hydrochloride Oral Solution
» Hydralazine Hydrochloride Oral Solution contains not less than 90.0 percent and not more than 110.0 percent of the labeled content of hydralazine hydrochloride (C8H8N4·HCl). Prepare Hydralazine Hydrochloride Oral Solution of the designated percentage strength as follows (see Pharmaceutical Compounding—Nonsterile Preparations 795):
note—Hydralazine reacts with many flavors; do not add flavors when compounding.
Hydralazine Hydrochloride
for 0.1% Oral Solution 100 mg
for 1.0% Oral Solution 1.0 g
Sorbitol Solution (70%) 40 g
Methylparaben 65 mg
Propylparaben 35 mg
Propylene Glycol 10 g
Aspartame 50 mg
Purified Water, a sufficient quantity to make 100 mL
Dissolve the Hydralazine Hydrochloride in 30 mL of Purified Water, add the Aspartame, and shake or stir until the solids have dissolved. Add the Sorbitol Solution. In a separate container, dissolve an aliquot portion of an intimate homogeneous mixture of accurately weighed quantities of Methylparaben and Propylparaben in the Propylene Glycol, and, with stirring, add this mixture to the solution containing the Hydralazine Hydrochloride. Add sufficient Purified Water to make the product measure 100 mL, and mix.
Packaging and storage— Preserve in a suitable light-resistant glass or plastic bottle, with a child-resistant closure. Store in a refrigerator.
Labeling— Label it to state, as part of the official title, the content of Hydralazine Hydrochloride expressed as a percentage and parenthetically (mg per 5 mL). Label it to state that it is to be stored in a refrigerator. The label indicates that patients may mix the appropriate dose with fruit juice or apple sauce just prior to administration. [Precaution—Phenylketonurics: It contains 1.4 mg of phenylalanine per teaspoonful (5 mL).]
pH 791: an apparent pH between 3.0 and 5.0.
Beyond-use date— Thirty days after the day on which it was compounded.
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
(CRX05) Compounding Pharmacy05
USP32–NF27 Page 2565
Pharmacopeial Forum: Volume No. 28(2) Page 306