Development of N-Acetylneuraminic Acid Reference Material from Fermentation Products

N-acetylneuraminic acid (NANA) is a key ingredient in bird’s nest, as well as in health products and infant formulas. However, the absence of suitable reference materials (RMs) makes it challenging to ensure the quality of these products. Currently, NANA is primarily extracted from bird’s nest, but this process is costly and difficult to scale up. In this study, we successfully prepared a large-scale yield of NANA RM from fermentation products, which increases the yield of the RM and reduces its cost. IR, MS, and NMR methods were used for the qualitative analysis of the NANA RM, and HPLC was used for homogeneity and stability testing. The F test showed that the NANA RM remained stable over a 12-month period. In collaboration with eight quantification laboratories in China, the certified value and uncertainty of the NANA RM were calculated. The certified value of the NANA RM is 98.26%, with an expanded uncertainty of 0.10% (k = 2). This prepared NANA RM can now be used for quality control in bird’s nest, health products, infant-formula-related food products, medicine, and cosmetics.