Caramel
(kar' a mel).
DEFINITION
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). ]
IMPURITIES
• Arsenic, Method II 
211
:
NMT 3 ppm
211:
NMT 3 ppm
• Lead 251:
NMT 10 ppm
251:
NMT 10 ppm
• Ash:
It swells when incinerated, and forms a coke-like charcoal that burns off only after prolonged heating at a high temperature. It yields NMT 8.0% of ash.
SPECIFIC TESTS
• Microbial Enumeration Tests 61 and Tests for Specified Microorganisms 62:
Meets the requirements of the tests for absence of Salmonella species and Escherichia coli
61 and Tests for Specified Microorganisms 62:
Meets the requirements of the tests for absence of Salmonella species and Escherichia coli
• Specific Gravity 841:
NLT 1.30
841:
NLT 1.30
• Purity:
The addition of 0.5 mL of phosphoric acid to 20 mL of a solution (1 in 20) produces no precipitate.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Robert H. Lafaver, M.S.
Scientific Liaison 1-301-816-8335 |
(EXC2010) Monographs - Excipients |
| 61 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| 62 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
USP35–NF30 Page 1728