Merck

Use of aspartame in pregnancy.

International journal of fertility (1985-01-01)
F M Sturtevant
ABSTRACT

The low-calorie sweetening agent, aspartame, is broken down in the small intestine into three moieties: aspartic acid, methanol and phenylalanine. Acute loading studies have been performed in human beings who received up to six times the 99th percentile of the projected daily intake (6 X 34 = 200 mg/kg). No evidence of risk to the fetus was developed. Aspartate does not readily cross the placenta. Small elevations of blood methanol following such abuse doses of aspartame did not lead to measurable increases of blood formic acid, which is the product responsible for the acidosis and ocular toxicity in methanol poisoning. Phenylalanine is concentrated on the fetal side of the placenta. Aspartame in abuse doses up to 200 mg/kg in normal subjects, or to 100 mg/kg in PKU heterozygotes, did not raise blood phenylalanine levels to the range generally accepted to be associated with mental retardation in the offspring. It is concluded that, under foreseeable conditions of use, aspartame poses no risk for use in pregnancy.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Asp-Phe methyl ester, ≥98%
Supelco
Aspartame, analytical standard
USP
Aspartame, United States Pharmacopeia (USP) Reference Standard
Aspartame, European Pharmacopoeia (EP) Reference Standard
Supelco
Aspartame, Pharmaceutical Secondary Standard; Certified Reference Material