9/16/2017 USP Monographs: Biotin

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Biotin

C10H16N2O3S 244.31

1H-Thieno3,4-dimidazole-4-pentanoic acid, hexahydro-2-oxo-, 3aS-(3a ,4 ,6a )-.

(3aS,4S,6aR)-Hexahydro-2-oxo-1H-thieno3,4-dimidazole-4-valeric acid [58-85-5].

» Biotin contains not less than 97.5 percent and not more than 100.5 percent of C10H16N2O3S.

Packaging and storage— Store in tight containers.

USP Reference standards 11 — USP Biotin RS.

Identification, Infrared Absorption 197K .

Specific rotation 781S : between +89 and +93 .

Test solution: 20 mg per mL, in 0.1 N sodium hydroxide.

Organic volatile impurities, Method V 467 : meets the requirements.

Solvent— Use dimethyl sulfoxide.

Residual solvents 467 : meets the requirements.

(Official January 1, 2007)

Assay— Mix about 500 mg, accurately weighed, of Biotin with 100 mL of water, add phenolphthalein TS, and titrate the
suspension slowly with 0.1 N sodium hydroxide VS, while heating and stirring continuously. Each mL of 0.1 N sodium
hydroxide is equivalent to 24.43 mg of C10H16N2O3S.

Auxiliary Information— Staff Liaison : Lawrence Evans, III, Ph.D., Scientist

Expert Committee : (DSN05) Dietary Supplements - Non-Botanicals
USP29–NF24 Page 283
Phone Number : 1-301-816-8389

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