Chocolate
»Chocolate is a powder prepared from the roasted,cured kernels of the ripe seed of Theobroma cacaoL.(Fam.Sterculiaceae).Chocolate yields not less than 10.0percent and not more than 22.0percent 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 15µm in diameter,and they stain slowly with iodine TS.
Microbial limits á61ñ— The total bacterial count does not exceed 5000cfu 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 105for 1hour,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 á561ñ: not more than 8.0%.
Acid-insoluble ash á561ñ: not more than 0.4%.
Crude fiber á561ñ: not more than 7.0%.
Assay— Extract about 10g of Chocolate,accurately weighed,with anhydrous ethyl ether in a continuous-extraction apparatus for 8hours.Allow the ether solution to evaporate spontaneously in a suitable tared container,dry at 105for 1hour,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:(CRX)Compounding Pharmacy
USP28–NF23Page 2989
Pharmacopeial Forum:Volume No.27(4)Page 2795
Phone Number:1-301-816-8243