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 CompoundingNonsterile Preparations á795ñ):
NOTEHydralazine reacts with many flavors;do not add flavors when compounding.
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.[PrecautionPhenylketonurics: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
USP28NF23Page 953
Pharmacopeial Forum:Volume No.28(2)Page 306
Phone Number:1-301-816-8243
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