Printed on: Thu Feb 16 2023, 10:50:23 PM(EST) Status: Currently Official on 17-Feb-2023 DocId: GUID-C036F962-7999-4C07-96B5-D179A3BB3C7C_2_en-US

Printed by: Maria Christina Official Date: Official Prior to 2013 Document Type: DIETARY SUPPLEMENTS @2023 USPC
Do Not Distribute DOI Ref: g19br DOI: https://doi.org/10.31003/USPNF_M2492_02_01
1

Chromatographic system
Curcuminoids Capsules
DEFINITION
Curcuminoids Capsules are prepared from Curcuminoids and
contain NLT 90.0% and NMT 110.0% of the labeled amount
of curcuminoids, calculated as the sum of curcumin,
desmethoxycurcumin, and bisdesmethoxycurcumin.
System suitability
IDENTIFICATION
• A. THIN-LAYER CHROMATOGRAPHY
Standard solution: 0.2 mg/mL of USP Curcuminoids RS in
acetone
Sample solution: Weigh and finely powder the contents of
NLT 20 Capsules. Transfer a portion of the powder,
equivalent to about 10 mg of curcuminoids, to a suitable
container, add 5 mL of acetone, shake for 1 min, and
sonicate for 10 min. Allow to stand for 15 min before use.
Adsorbent: Chromatographic silica gel mixture with an
average particle size of 10–15 µm (TLC plates)
Application volume: 10 µL, as bands
Developing solvent system: Chloroform, methanol, and
formic acid (96:4:1)
(See Chromatography á621ñ, System Suitability.)
Mode: LC
Detector: UV-Vis 420 nm
Column: 4.6-mm × 25-cm; 5-µm packing L1
Flow rate: 1 mL/min
Injection size: 20 µL
Sample: Standard solution A
[NOTE—The relative retention times for the curcumin,
desmethoxycurcumin, and bisdesmethoxycurcumin
peaks are about 1.0, 1.2, and 1.4, respectively.]
Suitability requirements
Chromatogram similarity: The chromatogram from
Standard solution A is similar to the Reference
Chromatogram provided with the lot of USP
Curcuminoids RS being used.
Resolution: NLT 2.0 between the curcumin and
desmethoxycurcumin peaks and the
desmethoxycurcumin and bisdesmethoxycurcumin
peaks
Tailing factor: NMT 1.5 for the bisdesmethoxycurcumin,

Analysis
Samples: Standard solution and Sample solution
Apply the samples as bands to a suitable thin-layer
chromatographic plate (see Chromatography á621ñ).
Use a saturated chamber. Develop the chromatograms
until the solvent front has moved up about three-fourths
of the length of the plate. Remove the plate from the
chamber, dry, and examine under UV light at 365 nm.
Acceptance criteria: The Sample solution chromatogram
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shows yellowish-brown bands due to
bisdesmethoxycurcumin, desmethoxycurcumin, and
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curcumin at RF values of about 0.4, 0.6, and 0.7,
respectively, corresponding in position and color to those
obtained from the Standard solution.
• B. The retention times of the peaks for curcumin,
desmethoxycurcumin, and bisdesmethoxycurcumin of the
Sample solution correspond to those of the Standard
O
al
desmethoxycurcumin, and curcumin peaks
Relative standard deviation: NMT 2.0% for
desmethoxycurcumin peak, in repeated injections
Analysis
Samples: Standard solution A, Standard solution B, Standard
solution C, Standard solution D, and Sample solution
Calculate the quantity, in mg, of curcumin,
desmethoxycurcumin, and bisdesmethoxycurcumin in
each Capsule:
Result = (rU/rS) × CS × D × V × (WF/WU)
rU = peak area for curcumin, desmethoxycurcumin, or
bisdesmethoxycurcumin from the Sample
solution
rS = peak area for curcumin, desmethoxycurcumin, or
bisdesmethoxycurcumin from the appropriate

solution for the appropriate USP Reference Standard, as Standard solution

obtained in the test for Content of Curcuminoids. CS = concentration of the appropriate Standard
solution (mg/mL)
STRENGTH D = dilution factor to prepare the Sample solution
• CONTENT OF CURCUMINOIDS from Sample stock solution
Mobile phase: Tetrahydrofuran and 1 mg/mL of citric acid V = volume of Sample stock solution (mL)
in water (4:6) WF = average fill weight of Capsules (mg)
[NOTE—Sonication may be necessary to dissolve the RS WU = weight of content of Capsules taken to prepare
in each Standard solution; all solutions should be the Sample stock solution (mg)
passed through a filter with 0.45-µm pore size before
injection. USP Curcumin RS, USP Calculate the percentage of the labeled amount of
Desmethoxycurcumin RS, and USP curcuminoids in the Capsule:
Bisdesmethoxycurcumin RS can also be prepared in
one standard solution containing the final Result = (ΣQ/L) × 100
concentration specified below for each.]
Standard solution A: 40 µg/mL of USP Curcuminoids RS in ΣQ = sum of the quantities of curcumin,
Mobile phase desmethoxycurcumin, and
Standard solution B: 40 µg/mL of USP Curcumin RS in bisdesmethoxycurcumin in the Capsule (mg)
Mobile phase L = labeled amount of curcuminoids (mg/Capsule)
Standard solution C: 10 µg/mL of USP
Desmethoxycurcumin RS in Mobile phase Acceptance criteria: 90.0%–110.0% of the label claim
Standard solution D: 2 µg/mL of USP PERFORMANCE TESTS
Bisdesmethoxycurcumin RS in Mobile phase • DISINTEGRATION AND DISSOLUTION á2040ñ
Sample stock solution: Weigh and finely powder the Mode: Dissolution
contents of NLT 20 Capsules. Transfer an accurately Medium: Water containing 1% sodium lauryl sulfate;
weighed amount of the powder, equivalent to about 20 mg 900 mL
of curcuminoids, to a 50-mL volumetric flask. Add about Apparatus 2: 100 rpm
30 mL of acetone, sonicate for 30 min, dilute with acetone Time: 60 min
to volume, mix, and centrifuge. Sample solution: Combine 25-mL portions of the solution
Sample solution: Dilute a portion of the Sample stock under test from each of the six dissolution vessels, and mix.
solution 1 in 10 with Mobile phase, and mix.

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Printed on: Thu Feb 16 2023, 10:50:23 PM(EST) Status: Currently Official on 17-Feb-2023 DocId: GUID-C036F962-7999-4C07-96B5-D179A3BB3C7C_2_en-US
Printed by: Maria Christina Official Date: Official Prior to 2013 Document Type: DIETARY SUPPLEMENTS @2023 USPC
Do Not Distribute DOI Ref: g19br DOI: https://doi.org/10.31003/USPNF_M2492_02_01
2

Transfer 5 mL to a 25-mL volumetric flask, and dilute with • ABSENCE OF SPECIFIED MICROORGANISMS á2022ñ: Meet the
Mobile phase to volume. requirements of the tests for the absence of Salmonella
Analysis: Determine the amount of curcumin (C21H20O6) species and Escherichia coli
dissolved by using the method used in Strength, making
ADDITIONAL REQUIREMENTS
any necessary modifications.
• PACKAGING AND STORAGE: Preserve in well-closed
Tolerances: NLT 75% of the content of curcumin (C21H20O6)
containers, protect from light and moisture, and store at
is dissolved. room temperature.
• WEIGHT VARIATION OF DIETARY SUPPLEMENTS á2091ñ: • LABELING: The label states the content of curcuminoids in
Meet the requirements mg/Capsule.
CONTAMINANTS • USP REFERENCE STANDARDS á11ñ
• MICROBIAL ENUMERATION TESTS á2021ñ: The total aerobic USP Bisdesmethoxycurcumin RS
bacterial count does not exceed 104 cfu/g, and the total USP Curcumin RS
combined molds and yeasts count does not exceed 103 cfu/ USP Curcuminoids RS
g. USP Desmethoxycurcumin RS

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