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June 14, 1996
Dioctyl Sodium Sulfosuccinate
DSS, Docusate Sodium
C2H5
COO CH2
CH (CH2)3
CH3
CH (CH2)3
CH3
CH2
CH SO3Na
COO
CH2
C2H5
C20H37NaO7S
Formula wt 444.56
INS: 480
CAS: [577-11-7]
DESCRIPTION
A white, waxlike, plastic solid having a characteristic odor suggestive of octyl alcohol. It is free from the odor of
other solvents. One g dissolves slowly in about 70 mL of water. It is freely soluble in alcohol and in glycerin, and is
very soluble in solvent hexane.
Functional Use in Foods Emulsifier; wetting agent.
REQUIREMENTS
Identification Dry 50 mg of the sample at 105 for 2 h, cool, and immediately dissolve in 2 mL of carbon
tetrachloride. The infrared absorption spectrum of the solution, measured in 0.1-mm cells, exhibits maxima only at
the same wavelengths as that of a similar preparation of USP Dioctyl Sodium Sulfosuccinate Reference Standard,
previously dried in the same manner.Place a small piece of the sample on a salt plate, add 1 drop of acetone, and
promptly cover with another salt plate. Rub the plates together to dissolve the specimen, slide the plates apart, and
allow the acetone to evaporate. The infrared absorption spectrum of the film so obtained exhibits maxima only at
the same wavelengths as that of a similar preparation of USP Docusate Sodium Reference Standard.
Assay Not less than 98.5% of C20H37NaO7S, calculated on the dried basis.
Bis(2-ethylhexyl)maleate Not more than 0.4%.
Clarity of Solution Passes test.
Set the polarizing voltage of a suitable, previously calibrated polarograph (Metrohm Polarocord E-261 or
equivalent) at 1.3 V, adjust the current sensitivity to the lowest range (most sensitive) at which the current
oscillations will remain on scale, and record the polarogram, scanning a voltage range of 0.9 V to 1.5 V at this
sensitivity and using a saturated calomel electrode as the reference electrode. Record the average oscillations, in
mm, at 1.3 V as A, and those at 1.0 V as B.
Note: If a manual polarograph is used, record the average oscillations of the solutions at 1.3 V
and 1.0 V, respectively.
Repeat the entire procedure using Test Solution B, recording the average oscillations at 1.3 V as D, and those
at 1.0 V as E. Similarly, repeat the entire procedure using the Blank, recording the average oscillations at 1.3 V
as G, and those at 1.0 V as H.
Calculation Make the following preliminary calculations (in mA) to obtain C (net diffusion current of Test
Solution A); F (net diffusion current of Test Solution B); I (net current introduced by the Blank); J (diffusion
current due to added maleate); and K (diffusion current due to originally present maleate):
C = (A B) S1,
F = (D E) S2,
I = (G H) S3,
J = F C,
K = C I,
in which S1, S2, and S3 represent the current sensitivities used for Test Solution A, Test Solution B, and the Blank,
respectively.
Finally, calculate the percentage of bis(2-ethylhexyl)maleate in the original sample taken by the formula
(K 50WA)/(J WS).
Clarity of Solution Dissolve 25 g in 94 mL of alcohol. The solution does not develop a haze within 24 h.
Heavy Metals Ignite 2 g in a platinum crucible until free from carbon, cool, moisten the residue with 1 mL of
hydrochloric acid, and evaporate to dryness on a steam bath. Add 2 mL of 1 N acetic acid, digest on a steam bath
for 5 min, filter into a 50-mL Nessler tube, and wash the residue with sufficient water to make 25 mL. This
solution meets the requirements of the Heavy Metals Test, Appendix IIIB, using 20 g of lead ion (Pb) in the
control (Solution A).
Loss on Drying, Appendix IIC Dry at 105 for 2 h.
Residue on Ignition Ignite 1 g as directed in the general method, Appendix IIC.
Packaging and Storage Store in well-closed containers.