Biotin
C10H16N2O3S244.31
1H-Thieno[3,4-d]imidazole-4-pentanoic acid, hexahydro-2-oxo-, [3aS-(3a
,4
,6a)]-;
(3aS,4S,6aR)-Hexahydro-2-oxo-1H-thieno[3,4-d]imidazole-4-valeric acid
[58-85-5].
(bye' oh tin).
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C10H16N2O3S244.31
1H-Thieno[3,4-d]imidazole-4-pentanoic acid, hexahydro-2-oxo-, [3aS-(3a
,4,6a)]-; (3aS,4S,6aR)-Hexahydro-2-oxo-1H-thieno[3,4-d]imidazole-4-valeric acid
[58-85-5].DEFINITION
Biotin contains NLT 97.5% and NMT 100.5% of biotin (C10H16N2O3S).
IDENTIFICATION
ASSAY
• Procedure
Sample: 500 mg of Biotin
Blank: 100 mL of water
Titrimetric system
(See Titrimetry 
541
.)
541.)Mode: Direct titration
Titrant: 0.1 N sodium hydroxide VS
Endpoint detection: Visual
Analysis
Mix the Sample with 100 mL of water. Add phenolphthalein TS, and titrate the suspension slowly with the Titrant while heating and stirring continuously. Perform the Blank determination.
Calculate the percentage of biotin (C10H16N2O3S) in the Sample taken:
Result = {[(VS 
VB) × N × F]/W} × 100
VB) × N × F]/W} × 100| VS | = | = Titrant volume consumed by the Sample (mL) |
| VB | = | = Titrant volume consumed by the Blank (mL) |
| N | = | = actual normality of the Titrant (mEq/mL) |
| F | = | = equivalency factor: 244.3 mg/mEq |
| W | = | = Sample weight (mg) |
Acceptance criteria: 97.5%–100.5%
SPECIFIC TESTS
• Optical Rotation, Specific Rotation 781S
781S Sample solution: 20 mg/mL in 0.1 N sodium hydroxide
Acceptance criteria: +89
to +93
to +93ADDITIONAL REQUIREMENTS
• Packaging and Storage: Store in tight containers.
• USP Reference Standards 11
11 USP Biotin RS 
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Auxiliary Information— Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Huy T. Dinh, M.S. Scientific Liaison 1-301-816-8594 | (DS2010) Monographs - Dietary Supplements |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2362
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 35 or NF 30.