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Biotin Monograph for Chemists

This document provides information on the USP monograph for Biotin, including its chemical name, structure, packaging and storage requirements, identification tests, purity tests, and assay method. It lists the acceptable ranges for specific rotation and content, and specifies solvents and reference standards used. The liaison and expert committee responsible for the monograph are also provided.

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Biolex Pharma
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471 views1 page

Biotin Monograph for Chemists

This document provides information on the USP monograph for Biotin, including its chemical name, structure, packaging and storage requirements, identification tests, purity tests, and assay method. It lists the acceptable ranges for specific rotation and content, and specifies solvents and reference standards used. The liaison and expert committee responsible for the monograph are also provided.

Uploaded by

Biolex Pharma
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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9/16/2017 USP Monographs: Biotin

Search USP29 Go

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

http://www.pharmacopeia.cn/v29240/usp29nf24s0_m9515.html 1/1

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