Hydralazine Hydrochloride Compounded Oral Solution
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Hydralazine Hydrochloride Compounded Oral Solution contains NLT 90.0% and NMT 110.0% of the labeled amount of hydralazine hydrochloride (C8H8N4 · HCl).
Prepare Hydralazine Hydrochloride Compounded Oral Solution of the designated percentage strength as follows (see Pharmaceutical Compounding—Nonsterile Preparations 〈795〉).
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 |
Puried Water, a sucient 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 preparation measure 100 mL, and mix.
[Note—Hydralazine reacts with many flavors; do not add flavors when compounding.]
2 SPECIFIC TESTS
pH 〈791〉: 3.0–5.0
3 ADDITIONAL REQUIREMENTS
Packaging and Storage: Package in a suitable light-resistant glass or plastic bottle, with a child-resistant closure. Store in a refrigerator.
Beyond-Use Date: NMT 30 days after the date on which it was compounded when stored in a refrigerator
Labeling: Label it to state the Beyond-Use Date and that it is to be stored in a refrigerator.
