Caramel
»Caramel is a concentrated solution of the product obtained by heating sugar or glucose until the sweet taste is destroyed and a uniform dark brown mass results,a small amount of alkali or of alkaline carbonate or a trace of mineral acid being added while heating.
NOTE—Where included in articles for coloring purposes,Caramel complies with the regulations of the FDAconcerning color additives (21CFR73.85,caramel).
Packaging and storage— Preserve in tight containers.
Specific gravity á841ñ: not less than 1.30.
Purity— The addition of 0.5mLof phosphoric acid to 20mLof a solution (1in 20)produces no precipitate.
Microbial limits á61ñ— It meets the requirements of the tests for absence of Salmonellaspecies and Escherichia coli.
Ash— It swells when incinerated,and forms a coke-like charcoal that burns off only after prolonged heating at a high temperature.It yields not more than 8.0%of ash.
Lead á251ñ: 10ppm.
Auxiliary Information— Staff Liaison:Catherine Sheehan,B.Sc.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 2972
Phone Number:1-301-816-8262