U.S. PHARMACOPEIA

Search USP29  
Chocolate
» Chocolate is a powder prepared from the roasted, cured kernels of the ripe seed of Theobroma cacao L. (Fam. Sterculiaceae). Chocolate yields not less than 10.0 percent and not more than 22.0 percent of nonvolatile, ether-soluble extractive.
Packaging and storage— Preserve in well-closed containers.
Botanic characteristics— 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.
Microbial limits 61 The total bacterial count does not exceed 5000 cfu per g, and it meets the requirements of the tests for absence of Escherichia coli, a 10-g specimen being used.
Limit of ether-insoluble residue— Separate portions of the ether-insoluble residue obtained in the Assay, previously dried at 105 for 1 hour, meet the requirements of the following tests.
Microscopic examination: few or no fragments of cocoa shells and no cereal starch grains are observed.
Total ash 561: not more than 8.0%.
Acid-insoluble ash 561: not more than 0.4%.
Crude fiber 561: not more than 7.0%.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Extract about 10 g of Chocolate, accurately weighed, with anhydrous ethyl ether in a continuous-extraction apparatus for 8 hours. Allow the ether solution to evaporate spontaneously in a suitable tared container, dry at 105 for 1 hour, and weigh the nonvolatile ether-soluble extractive. [NOTE—Retain the ether-insoluble residue for the test for Limit of ether-insoluble residue.]
Auxiliary Information— Staff Liaison : Claudia C. Okeke, Ph.D., Associate Director
Expert Committee : (CRX05) Compounding Pharmacy05
USP29–NF24 Page 3313
Pharmacopeial Forum : Volume No. 27(4) Page 2795
Phone Number : 1-301-816-8243