Failure of prescription prenatal vitamin products to meet USP standards for folic acid dissolution.
OBJECTIVE
To determine whether prescription prenatal vitamins meet United States Pharmacopeial Convention (USP) standards for folic acid dissolution.


METHODS
Dissolution was measured using USP Apparatus II and test conditions specified in the 23rd revision of the United States Pharmacopeia (USP 23). Folic acid was assayed by a chromatographic method modified from that specified in the official monographs, for oil- and water-soluble vitamins with minerals tablets, in USP 23.


RESULTS
Only three out of nine multivitamin products met USP specifications for folic acid release. Most missed by a wide margin; folic acid dissolution from two products was less than 25%.


CONCLUSIONS
Because a wide variety of brand-name and generic prescription prenatal multivitamin products were tested, these results are likely to be representative of the multivitamin products on the market. Given the significance of folic acid to public health, the authors believe that this subject should be studied further and that prompt action should be taken to ensure that folic-acid-containing products are of the highest quality possible.
Hoag
S W
SW
University of Maryland at Baltimore, School of Pharmacy, USA.
Ramachandruni
H
H
Shangraw
R F
RF
D002626:Chemistry, Pharmaceutical; D005260:Female; D005492:Folic Acid / Q000737:chemistry*; D006801:Humans; D011247:Pregnancy; D011295:Prenatal Care; D011786:Quality Control; D012995:Solubility; D014815:Vitamins / Q000737:chemistry*
D014815:Vitamins; D005492:Folic Acid