ALIDATION OF A GAS CHROMATOGRAPHIC METHOD FOR DETERMINATION OF ETHANOL IN LIQUID PREPARATIONS INTENDED FOR CHILDREN

Abstract

In 1984, the American Academy of Pediatrics recommended limiting alcohol content to no more than 5% and restricting the volume of products
containing alcohol to non‐lethal quantities. In 1993, a committee representing the Food and Drug Administration and the Nonprescription Drug
Manufacturers Association agreed to develop voluntary limits for the alcohol content of liquid dosage preparations. The committee concluded that
all over‐the‐counter products designed for children less than six years of age should be alcohol‐free. Products labeled for children 6‐12 years of age
should contain no more than 5% alcohol. Products for children over 12 years and adults should be limited to 10% alcohol content. In certain
products requiring higher alcohol contents to achieve solubility, warning labels would instruct parents to contact a physician prior to giving these
products to children. To date, limited documentation of such interaction exists because of a lack of scientific studies on this subject. Hence attempt
was made to evaluate quantity as well as quality aspects in terms of contamination from menthol, camphor and propylene glycol.