Hydralazine Hydrochloride Oral Solution
»Hydralazine Hydrochloride Oral Solution contains not less than 90.0percent and not more than 110.0percent 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 á795ñ):
NOTE—Hydralazine reacts with many flavors;do not add flavors when compounding.
Hydralazine Hydrochloride
for 0.1%Oral Solution 100mg
for 1.0%Oral Solution 1.0g
Sorbitol Solution (70%) 40g
Methylparaben 65mg
Propylparaben 35mg
Propylene Glycol 10g
Aspartame 50mg
Purified Water,a sufficient
quantity to make 100mL
Dissolve the Hydralazine Hydrochloride in 30mLof 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 100mL,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 5mL).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 1.4mg of phenylalanine per teaspoonful (5mL).]
pHá791ñ: an apparent pHbetween 3.0and 5.0.
Beyond-use date— Thirty days after the day on which it was compounded.
Auxiliary Information— Staff Liaison:Claudia C.Okeke,Ph.D.,Associate Director
Expert Committee:(CRX)Compounding Pharmacy
USP28–NF23Page 953
Pharmacopeial Forum:Volume No.28(2)Page 306
Phone Number:1-301-816-8243