Caramel

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Caramel

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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 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).]

2 IMPURITIES

Change to read:

  • ARSENIC (211), Procedures, Procedure 2 (CN 1-JUN-2023): NMT 3 ppm

Change to read:

  • LEAD (251), Procedures. Procedure 1 (CN 1-JUN-2023): 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.

3 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

SPECIFIC GRAVITY (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.

4 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in tight containers.

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