U.S. PHARMACOPEIA

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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 FDA concerning color additives (21 CFR 73.85, caramel).
Packaging and storage— Preserve in tight containers.
Specific gravity 841: not less than 1.30.
Purity— The addition of 0.5 mL of phosphoric acid to 20 mL of a solution (1 in 20) produces no precipitate.
Microbial limits 61 It meets the requirements of the tests for absence of Salmonella species 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 251: 10 ppm.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Auxiliary Information— Staff Liaison : Catherine Sheehan, B.Sc., Scientist
Expert Committee : (EM105) Excipient Monographs 1
USP29–NF24 Page 3292
Phone Number : 1-301-816-8262