Abstract

The pH profile of the lactose browning reaction was ascertained with various buffers under accelerated stability conditions and compared to the pH browning profile obtained by similar procedures for both dextrose and galactose. The effect of heat, humidity, and tablet lubricants was studied also. A correlation was found between the ultraviolet absorption spectrum and the 5-hydroxymethylfurfural content of samples of spray-dried lactose. The increase in absorption during the browning process afforded a simple procedure for studying this phenomenon. Also, absorption measurement could serve as a purity test for U.S.P. purposes. A procedure involving the use of anion exchange resins was developed for the purification of spray-dried lactose. This method should be adaptable to large scale commercial processes. Lactose which was spray-dried following this purification treatment was less susceptible to browning than the commercially available material.

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