Biotin, chemical structure, molecular formula, Reference Standards

Biotin

C10H16N2O3S 244.31

1H-Thieno3,4-dimidazole-4-pentanoic acid,hexahydro-2-oxo-,3aS-(3aa,4b,6aa)-.
(3aS,4S,6aR)-Hexahydro-2-oxo-1H-thieno3,4-dimidazole-4-valeric acid [58-85-5].

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

Packaging and storage— Store in tight containers.

USP Reference standards á11ñ— USP Biotin RS.

Identification,Infrared Absorption á197Kñ.

Specific rotation á781Sñ: between +89

and +93

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

Organic volatile impurities,Method Vá467ñ: meets the requirements.

Solvent— Use dimethyl sulfoxide.

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

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

Expert Committee:(DSN)Dietary Supplements:Non-Botanicals

USP28–NF23Page 260

Phone Number:1-301-816-8389