Chocolate
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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)
1 DEFINITION
Chocolate is a powder prepared from the roasted, cured kernels of the ripe seed of Theobroma cacao L. (Fam. Sterculiaceae). Chocolate yields NLT 10.0% and NMT 22.0% of nonvolatile ether-soluble extractive.
2 COMPOSITION
2.1 CONTENT OF NONVOLATILE ETHER-SOLUBLE EXTRACTIVE
Sample: 10 g of Chocolate
Analysis: Extract the Sample with anhydrous ethyl ether in a continuous-extraction apparatus for 8 h. Allow the ether solution to evaporate spontaneously in a suitable tared container, dry at 105° for 1 h, and weigh the nonvolatile ether-soluble extractive.
Acceptance criteria: 10.0%-22.0%
[NOTE-Retain the ether-insoluble residue for the test for Botanical Characteristics and the tests for Articles of Botanical Origin, Methods of Analysis, Total Ash; Acid-Insoluble Ash; and Crude Fiber.] MICROBIAL ENUMERATION TESTS (61) and TESTS FOR SPECIFIED MICROORGANISMS (62): The total bacterial count does not exceed 5 x 103 cfu / g and it
3 CONTAMINANTS
meets the requirements of the tests for absence of Escherichia coli, a 10-g specimen being used.
ARTICLES OF BOTANICAL ORIGIN (561), Pesticide Residue Analysis: Meets the requirements
4 SPECIFIC TESTS
4.1 BOTANICAL CHARACTERISTICS
Microscopic: It shows numerous broken parenchyma cells of the cotyledons containing a reddish brown or purplish brown to yellowish orange pigment; numerous starch grains; oil globules; aleurone grains; and occasionally acicular or prismatic crystals of fat. The starch grains are simple and two- to three-compound, the single grains up to 15 µm in diameter, and they stain slowly with iodine TS. The ether-insoluble residue retained from the Content of Nonvolatile Ether-Soluble Extractive shows few or no fragments of cocoa shells and no cereal starch grains.
4.2 ARTICLES OF BOTANICAL ORIGIN (561), Methods of Analysis, Total Ash
Sample: Use the ether-insoluble residue from the Content of Nonvolatile Ether-Soluble Extractive.
Acceptance criteria: NMT 8.0%
4.3 ARTICLES OF BOTANICAL ORIGIN (561), Methods of Analysis, Acid-Insoluble Ash
Sample: Use the ether-insoluble residue from the Content of Nonvolatile Ether-Soluble Extractive.
Acceptance criteria: NMT 0.4%
4.4 ARTICLES OF BOTANICAL ORIGIN (561), Methods of Analysis, Crude Fiber
Sample: Use the ether-insoluble residue from the Content of Nonvolatile Ether-Soluble Extractive.
Acceptance criteria: NMT 7.0%
5 ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in well-closed containers.
