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.
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 enumeration tests 61 and Tests for specified microorganisms 62—
It meets the requirements of the tests for absence of Salmonella species and Escherichia coli.
61 and Tests for specified microorganisms 62—
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.
Arsenic, Method II 211:
3 ppm.
211:
3 ppm.
Lead 251:
10 ppm.
251:
10 ppm.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
Chromatographic Column—
| Topic/Question | Contact | Expert Committee |
| Monograph | Robert H. Lafaver, B.A.
Scientist 1-301-816-8335 |
(EM105) Excipient Monographs 1 |
| 61 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
| 62 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
USP32–NF27 Page 1185
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.