Sennosides
(sen' oh sides).
DEFINITION
Sennosides is a partially purified natural complex of anthraquinone glucosides, isolated from senna leaflets and/or senna pods, Senna alexandrina Mill. (Cassia acutifolia Vahl or C. angustifolia Delile), as calcium salts. It contains NLT 90.0% and NMT 110.0% of the labeled amount of sennosides. The labeled amount is NLT 60.0% (w/w), calculated on the dried basis.
IDENTIFICATION
• A. Thin-Layer Chromatographic Identification Test
Solvent:
Ethyl acetate, n-propyl alcohol, and water (1:1:1). Shake well, and discard the upper layer.
Standard solution:
1 mg/mL of USP Sennosides RS in Solvent
Sample solution:
1 mg/mL of Sennosides in Solvent
Chromatographic system
Adsorbent:
0.25-mm layer of chromatographic silica gel mixture
Application volume:
20 µL
Developing solvent system:
Ethyl acetate, n-propyl alcohol, and water (4:4:3)
Analysis:
Apply the solutions, as 1-cm bands, on a line 2.5 cm from the bottom edge of a thin-layer chromatographic plate. Develop, and dry. Examine the plate under long-wavelength UV light. Expose the plate to ammonium hydroxide vapor until color develops (about 5 min). Cover the plate with a piece of glass, and heat at 120
for 5 min.
for 5 min.
Acceptance criteria:
The two most prominent spots from the Sample solution correspond in color and position to those of the Standard solution.
ASSAY
• Procedure
Buffer:
Dissolve 4.54 g of monobasic potassium phosphate in water to make 500 mL of solution. Dissolve 4.73 g of anhydrous dibasic sodium phosphate in water to make 500 mL of solution. Mix 38.9 mL of the monobasic potassium phosphate solution with 61.1 mL of the dibasic sodium phosphate solution. Adjust, if necessary, to a pH of 7.0 with the dibasic sodium phosphate solution.
Borate solution:
37.9 g/L of sodium borate in water
Sodium dithionite solution:
15 g/L of sodium dithionite in water
Standard solution:
1 mg/mL of USP Sennosides RS in Buffer. Dissolve with the aid of an ultrasonic bath.
Sample solution:
1 mg/mL of Sennosides in Buffer
Instrumental conditions
Mode:
Fluorescence
Excitation wavelength:
392 nm
Emission wavelength:
505 nm
Analysis
Samples:
Standard solution and Sample solution
Pipet 1-mL portions of the Standard solution and the Sample solution into separate 100-mL volumetric flasks, and dilute with Borate solution to volume. Transfer 5.0-mL portions of each of the resulting solutions to separate, low-actinic glass, 50-mL volumetric flasks. Add 15.0 mL of Borate solution and 15.0 mL of Sodium dithionite solution. Pass nitrogen through the solutions, seal the flasks with nitrogen-filled balloons, and heat in a water bath for 30 min. Cool the flasks for 15 min in a water bath thermostatically controlled at 20. Dilute the solutions with Borate solution to volume. Determine, without delay, the fluorescence intensities of the resulting solutions, for which the time elapsed between the addition of Sodium dithionite solution and the measurement is the same.
. Dilute the solutions with Borate solution to volume. Determine, without delay, the fluorescence intensities of the resulting solutions, for which the time elapsed between the addition of Sodium dithionite solution and the measurement is the same.Calculate the percentage of the labeled amount of sennosides in the Sample taken:
Result = (IU/IS) × (CS/CU) × 100
| IU | = | = fluorescence value observed in the Sample solution |
| IS | = | = fluorescence value observed in the Standard solution |
| CS | = | = concentration of USP Sennosides RS in the Standard solution, corrected for loss on drying (mg/mL) |
| CU | = | = concentration of sennosides in the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–110.0% of the labeled amount of sennosides
CONTAMINANTS
• Heavy Metals, Method II 
231
:
60 µg/g
231:
60 µg/g
SPECIFIC TESTS
• pH 791:
6.3–7.3, in a 100-mg/mL solution
791:
6.3–7.3, in a 100-mg/mL solution
• Residue on Ignition 281:
5.0%–8.0%, ignited at 800 ± 25, the use of sulfuric acid being omitted
281:
5.0%–8.0%, ignited at 800 ± 25, the use of sulfuric acid being omitted
• Loss on Drying 731:
Dry a sample in a vacuum at 100 to constant weight: it loses NMT 5.0% of its weight.
731:
Dry a sample in a vacuum at 100 to constant weight: it loses NMT 5.0% of its weight.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers. Store protected from light and moisture, at controlled room temperature.
• USP Reference Standards 11
11
USP Sennosides RS 
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Maged H. Sharaf, Ph.D.
Principal Scientific Liaison 1-301-816-8318 |
(DS2010) Monographs - Dietary Supplements |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4627
Pharmacopeial Forum: Volume No. 35(2) Page 309