Carrageenan analysis. Part 2: Quantification in swine-adapted infant formula

Area of Science:

• Analytical Chemistry
• Food Science and Technology
• Toxicology

Background:

• Carrageenan is a common food additive used to stabilize infant formulas.
• Assessing carrageenan levels in dietary formulations is crucial for safety evaluations in non-clinical studies.
• Regulatory guidelines, such as 21 CFR Part 58, mandate validated analytical methods for such studies.

Purpose of the Study:

• To validate an LC-MS/MS method for quantifying carrageenan in swine-adapted infant formula.
• To ensure accurate measurement of carrageenan concentrations used in a 28-day piglet dietary feeding study.

Main Methods:

• Method validation was performed according to Good Laboratory Practice (GLP) standards (21 CFR Part 58).
• Liquid Chromatography-tandem Mass Spectrometry (LC-MS/MS) with Electrospray Ionization (ESI) in negative-ion mode was employed for detection.
• Linearity was established for carrageenan detection within the range of 1.00-7.50 µg/mL.

Main Results:

• The LC-MS/MS method was successfully validated for the accurate measurement of carrageenan.
• The method demonstrated linearity over the specified concentration range, suitable for the study's requirements.
• Carrageenan concentrations in the test formulations ranged from 0 to 2250 mg/kg.

Conclusions:

• A robust and validated LC-MS/MS method is available for determining carrageenan concentrations in infant formula.
• This validated method supports the safety assessment of carrageenan in dietary studies involving piglets.
• The study adheres to Good Laboratory Practice standards, ensuring the reliability of analytical data for regulatory purposes.