11/9/2020 USP-NF Biotin Tablets
Printed on: Mon Nov 09 2020, 10:49:11 am
Printed by: Shruti Kharidia
O cial Status: Currently O cial on 09-Nov-2020
O cial Date: O cial as of 1-Dec-2013
Document Type: USP & DS
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Printed from: https://online.uspnf.com/uspnf/document/1_GUID-F9A08AA7-BF7E-464F-952F-DD00F13B57E4_1_en-US
© 2020 USPC
Biotin Tablets
DEFINITION
Biotin Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of biotin (C10H16N2O3S).
IDENTIFICATION
• A. 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
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.
Mobile phase: Acetonitrile and Buffer solution (8.5:91.5)
Diluent: Acetonitrile and water (1:4)
Standard solution: 0.05 mg/mL of USP Biotin RS in Diluent. Sonicate, if necessary, to dissolve.
Sample solution: Transfer a portion equivalent to 5 mg of biotin from NLT 30 nely powdered Tablets to a 100-mL volumetric ask,
add 60 mL of water, and shake in a water bath at 65° for 20 min. Sonicate for 5 min, shake by mechanical means for 15 min, and
cool to room temperature. Add 20 mL of acetonitrile, dilute with water to volume, and lter.
Chromatographic system
(See Chromatography 〈621〉, System Suitability.)
Mode: LC
Detector: UV 200 nm
Column: 4.6-mm × 15-cm; 3-µm packing L7 L
IA
Flow rate: 1.2 mL/min
Injection volume: 50 µL
System suitability
Sample: Standard solution
Suitability requirements
IC
Tailing factor: NMT 1.5
Relative standard deviation: NMT 2.0% for replicate injections
Analysis
Samples: Standard solution and Sample solution
FF
Calculate the percentage of biotin (C10H16N2O3S) in the portion of Tablets taken:
Result = (rU/rS) × (CS/CU) × 100
rU = peak response from the Sample solution
O
rS = peak response from the Standard solution
CS = concentration of USP Biotin RS in the Standard solution (mg/mL)
CU = nominal concentration of biotin in the Sample solution (mg/mL)
Acceptance criteria: 90.0%–110.0%
PERFORMANCE TESTS
• DISSOLUTION 〈711〉
Buffer solution: 0.02 N anhydrous disodium hydrogen phosphate adjusted with phosphoric acid to a pH of 7.4
Medium: Buffer solution; 500 mL
Apparatus 2: 75 rpm
Time: 1 h
Standard solution: Dissolve a suitable amount of USP Biotin RS in Buffer solution to obtain a concentration similar to that expected in
the Sample solution.
Sample solution: Withdraw a portion of the solution under test, pass through a suitable lter, and use the pooled sample as the test
specimen.
Analysis: Proceed as directed in the Assay, making any necessary adjustments.
Calculate the percentage of the labeled amount of biotin (C10H16N2O3S) dissolved:
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11/9/2020 USP-NF Biotin Tablets
Result = (rU/rS) × (CS × V/L) × 100
rU = peak area from the Sample solution
rS = peak area from the Standard solution
CS = concentration of USP Biotin RS in the Standard solution (µg/mL)
V = volume of Medium, 500 mL
L = labeled amount of biotin (µg/Tablet)
Tolerances: NLT 75% (Q) of the labeled amount of biotin (C10H16N2O3S) is dissolved.
• UNIFORMITY OF DOSAGE UNITS 〈905〉: Meet the requirements
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in tight, light-resistant containers.
• USP REFERENCE STANDARDS 〈11〉
USP Biotin RS
Auxiliary Information- Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
BIOTIN TABLETS Natalia Davydova NBDS2020 Non-botanical Dietary
Scienti c Liaison Supplements
Chromatographic Database Information: Chromatographic Database
Most Recently Appeared In:
L
IA
Pharmacopeial Forum: Volume No. 38(5)
Page Information:
USP43-NF38 - 571
IC
USP42-NF37 - 557
USP41-NF36 - 529
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