Biotin
(bye' oh tin).
Click to View Image

C10H16N2O3S 244.31
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 
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
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
Sample solution:  20 mg/mL in 0.1 N sodium hydroxide
Acceptance criteria:  +89 to +93
ADDITIONAL REQUIREMENTS
•  Packaging and Storage: Store in tight containers.
•  USP Reference Standards 11
USP Biotin RS Click to View Structure
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