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4436 IPEC
A. Macroscopic identification: To comply with monograph Description.
B. Microscopic identification:
Examined under a microscope, the transverse section of the root reveals a
bark made up of a thin brown suber layer, composed of polyhedric, tabular,
thin-walled cells, and a wide parenchymatous zone of phelloderm. The
phloem tissue consists of a narrow, non-lignified zone; the wood is dense,
mainly formed of narrow tracheids, interspersed with a smaller number of
vessels; tracheids and vessels have numerous areolate punctulations in their
lateral walls; the vessels have simple circular perforations. The cells of the
phelloderm and the medullary rays contain a large quantity of starch in the
form of single grains, or grains made up of 2 to 8 elements. Each grain is
oval, circular or semi-circular, rarely more than 15 µm in diameter; in the
parenchymatous zones, there are crystalliferous cells, each of which contains
a bundle of raphides, 30 to 80 µm in length. On the transverse section of an
internode, the rhizome has several thin-walled suber layers, a somewhat
collenchymatous cortical parenchyma, a pericycle containing large, clearly
canaliculate, sclerous cells, a narrow ring of phloem tissue, and a thick ring of
wood surrounding a pith made up of parenchymatous cells with thin
punctulated walls.
Cephaelis acuminata Karsten: On the whole, the starting material resembles
the root of Cephaelis ipecacuanha (Brot.) A. Rich., but the following
differences can be seen: It is often up to 9 mm in thickness, and the grayish-
brown to reddish-brown external surface has transversal narrowings at
intervals of about 1 to 3 mm. These narrowings, 0.5 to 1 mm in width, only
extend about halfway around the circumference and fade at the extremities.
The grains of starch can be up to 22 µm in diameter.
C. General identification tests:
If desired, the identification tests described below under the TINCTURE
heading may be done on the starting material by using a test solution in place
of the tincture. Prepare the test solution as follows:
To 0.1 g of the powdered dried starting material, add 0.05 ml of strong
ammonia solution and 5 ml of ethyl ether. Shake vigorously, occasionally,
over a period of 30 minutes, then filter.
Prepare a standard solution by dissolving 2.5 mg of emetine hydrochloride
and 3 mg of cephaeline dihydrochloride in 20.0 ml of methyl alcohol.
D. Additional tests:
Test 1:
Total ash: not more than 5.0% as per S & C Section - Total Ash
Determination.
Test 2:
Ash insoluble in hydrochloric acid: not more than 3.0% as per S & C
Section - Ash Insoluble in Hydrochloric Acid Determination.
Test 3:
 Loss on drying: not more than 10.0%, determined on 1.00 g of powdered
starting material, as per
S & C Section - Loss on Drying Determination.
Test 4:
Foreign matter: not more than 2.0% as per S & C Section - Foreign Matter
Determination.
Tincture (all quality control data is applicable to macerate tinctures only):
1. CHARACTERISTICS
A. Color: reddish-brown or yellowish-brown
B. Odor: aromatic
C. Taste: bitter, nauseating

2. IDENTIFICATION
Criteria for identification; tincture must meet all of the following tests:
Tests 1, 2, 3, 4, 5, and 7
or
Tests 3, 6, and 7
Test 1:
To 1 ml of the tincture, add 10 ml of water. Shake vigorously. An abundant
froth is produced.
Test 2:
To 2 ml of the tincture, add a few drops of 10.5% ferric chloride solution. A
dark green color appears.
Test 3:
To 1 ml of the tincture, add 0.2 ml of dilute hydrochloric acid and 0.15 ml of
mercuric potassium iodide solution. Turbidity is instantly produced and
rapidly increases.
Test 4:
Evaporate 10 ml of the tincture on a water bath. Dissolve the residue in 0.5
ml of 17% ammonia solution and shake with 10 ml of ethyl ether. Leave in
contact for 1 hour, then filter. Shake the ethyl ether phase with
diazobenzenesulfonic acid solution and add a few drops of strong sodium
hydroxide solution. The aqueous phase develops an orange-tinted red
color.
Test 5:
Shake 2 ml of the tincture with 10 ml of ethyl ether and a few drops of
strong ammonia solution. Separate the ethyl ether phase, then evaporate.
To the residue, add a few drops of sodium molybdate solution. A purplish,
then greenish color appears.
Test 6:
To 0.25 ml of the tincture, add 0.75 ml of dilute hydrochloric acid, then add
50 mg of chloramine T.
An orangish-yellow color is produced.
Test 7 (CHROMATOGRAPHY):
Test Solution: Evaporate 2 ml of the tincture on a water bath. Dissolve the
residue in 1 ml of strong ammonia solution and 5 ml of chloroform. Shake
vigorously and allow to stand for 30 minutes. Filter.
Reference Solution: Dissolve 4.6 mg of emetine hydrochloride and 5.7 mg
of cephaeline dihydrochloride in methyl alcohol, and dilute to 20 ml with
the same solvent.
Plate: silica gel of suitable grade
Application: 5 µl each of test solution and reference solution in 10 mm
bands
Mobile phase: chloroform + methyl alcohol (85+15)
Development: twice, over 10 cm
Drying: in air after each development
Detection 1: Spray with about 10 ml of chloroformic iodine solution and
heat at 60 °C for 10 minutes. Examine in daylight.
 Result 1 Reference Solution:
· a lemon-yellow band (emetine) in the center
· a light brown band (cephaeline) underneath the previous band
Result 1 Test Solution:
· a lemon-yellow band at about the position of the emetine band
· a light brown band at about the position of the cephaeline band
Detection 2: Examine under ultraviolet light at 365 nm.
Result 2 Reference Solution:
· the emetine band fluoresces intensely yellow
· the cephaeline band fluoresces light blue
Result 2 Test Solution:
· the band at about the position of the emetine band fluoresces
intensely yellow
· the band at about the position of the cephaeline band fluoresces light
blue
3. ALCOHOL CONTENT: 65% v/v (±15%) as per S & C Section - Alcohol
Determination.
4. DRY RESIDUE: not less than 0.9% w/w as per S & C Section - Dry Residue
Determination.
5. ASSAY:
The tincture should contain not less than 0.07% and not more than 0.18% of
total alkaloids, calculated as emetine (C29H40N2O4; m.w. 480.63).
Evaporate 75.0 g of the tincture to dryness. Add 100 ml of ethyl ether to the
residue, stir for 5 minutes and add 5 ml of dilute ammonia solution. Stir the
flask frequently for 1 hour and add 5 ml of water. Shake vigorously, then
decant the ethyl ether layer into a flask through a plug of cotton. Wash the
residue in the flask with two quantities, each of 25 ml of ethyl ether, decanting
each portion through the same plug of cotton. Combine the ethyl ether
solutions and eliminate the ethyl ether by distillation. Dissolve the residue in 2
ml of 90% v/v alcohol, evaporate the alcohol to dryness, and heat at 100 °C
for 5 minutes. Dissolve the residue in 5 ml of previously neutralized 90% v/v
alcohol, warming on a water bath. Add 15.0 ml of 0.1 N hydrochloric acid and
titrate the excess acid with 0.1 N sodium hydroxide solution, using 0.5 ml of
methyl red mixed indicator solution.
1 ml of 0.1 N hydrochloric acid is equivalent to 24.03 mg of total alkaloids,
calculated as emetine.
September, 2004
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