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 enumeration tests 
61
and Tests for specified microorganisms 62—
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.
61 and Tests for specified microorganisms 62—
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.
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%.
561:
not more than 8.0%.
Acid-insoluble ash 561:
not more than 0.4%.
561:
not more than 0.4%.
Crude fiber 561:
not more than 7.0%.
561:
not more than 7.0%.
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.]
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—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
| Monograph | Rick G. Schnatz
Manager, Compounding Pharmacy Expert Committee 1-301-816-8526 |
(CRX05) Compounding Pharmacy05 |
| 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 1206
Pharmacopeial Forum: Volume No. 27(4) Page 2795