11/9/2020 USP-NF Biotin
Printed on: Mon Nov 09 2020, 10:48:31 am
Printed by: Shruti Kharidia
O cial Status: Currently O cial on 09-Nov-2020
O cial Date: O cial as of 1-May-2020
Document Type: USP & DS
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© 2020 USPC
Biotin
C10H16N2O3S 244.31
1H-Thieno[3,4-d]imidazole-4-pentanoic acid, hexahydro-2-oxo-, [3aS-(3aα,4β,6aα)]-;
(3aS,4S,6aR)-Hexahydro-2-oxo-1H-thieno[3,4-d]imidazole-4-valeric acid [58-85-5]; UNII: 6SO6U10H04.
DEFINITION
Biotin contains NLT 97.5% and NMT 102.0% of biotin (C10H16N2O3S).
IDENTIFICATION
Change to read:
• A. ▲SPECTROSCOPIC IDENTIFICATION TESTS 〈197〉, Infrared Spectroscopy: 197K▲ (CN 1-MAY-2020)
• B. It meets the requirements in Speci c Tests for Optical Rotation〈781S〉, Speci c Rotation.
• C. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
ASSAY
• PROCEDURE
L
Buffer solution: Dissolve 1 g of sodium perchlorate monohydrate in 500 mL of water, add 1 mL of phosphoric acid, and dilute with
water to 1000 mL.
IA
Mobile phase: Acetonitrile and Buffer solution (8.5:91.5)
Diluent: Acetonitrile and water (1:4)
Standard solution: 0.1 mg/mL of USP Biotin RS in Diluent. Sonicate if necessary to dissolve.
Sample solution: 0.1 mg/mL of Biotin in Diluent. Sonicate if necessary to dissolve.
Chromatographic system
IC
(See Chromatography 〈621〉, System Suitability.)
Mode: LC
Detector: UV 200 nm
Column: 4.6-mm × 15-cm; 3-µm packing L7
FF
Flow rate: 1.2 mL/min
Injection volume: 50 µL
System suitability
Sample: Standard solution
Suitability requirements
O
Tailing factor: NMT 1.5
Relative standard deviation: NMT 2.0% for replicate injections
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of biotin (C10H16N2O3S) in the portion of Biotin taken:
Result = (rU/rS) × (CS/CU) × 100
rU = peak response from the Sample solution
rS = peak response from the Standard solution
CS = concentration of USP Biotin RS in the Standard solution (mg/mL)
CU = concentration of Biotin in the Sample solution (mg/mL)
Acceptance criteria: 97.5%–102.0%
IMPURITIES
• RELATED COMPOUNDS
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11/9/2020 USP-NF Biotin
Buffer solution, Mobile phase, Diluent, Standard solution, Sample solution, Chromatographic system, and System
suitability: Proceed as directed in the Assay.
Analysis
Sample: Sample solution
Measure the peak responses of the Sample solution.
Calculate the percentage of each impurity in the portion of Biotin taken:
Result = (rU/rT) × 100
rU = peak response of each impurity from the Sample solution
rT = sum of the peak responses of all the peaks from the Sample solution
Acceptance criteria
Individual impurity: NMT 1.0%
Total impurities: NMT 2.0%
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
Auxiliary Information- Please
Topic/Question Contact
L
check for your question in the FAQs before contacting USP.
Expert Committee
IA
BIOTIN Natalia Davydova NBDS2020 Non-botanical Dietary
Scienti c Liaison Supplements
IC
Chromatographic Database Information: Chromatographic Database
Most Recently Appeared In:
Pharmacopeial Forum: Volume No. 39(6)
FF
Page Information:
USP43-NF38 - 569
USP42-NF37 - 555
USP41-NF36 - 528
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