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7646 RUMX
Starting Material:
A. Macroscopic identification: To comply with monograph Description.
B. Microscopic identification:
A transverse section reveals, from the outside to the inside, a thin suber
layer, a cortical parenchyma with a large amount of starch grains and
calcium oxalate macles, and vascular clusters in the form of lozenges,
separated by medullary rays and scattered over several concentric circles.
Tincture (all quality control data is applicable to macerate tinctures only):
1. CHARACTERISTICS
A. Color: reddish-brown to yellowish-brown
B. Odor: spicy/earthy
C. Taste: slightly acrid
2. IDENTIFICATION
Criteria for identification; tincture must meet all of the following tests:
Tests 1, 2, and 3 (Procedure A)
or
Tests 1, 2, and 3 (Procedure B)
Test 1:
To 1 ml of the tincture, add a few drops of 10.5% ferric chloride solution.
A dark green color is produced.
Test 2:
To 1 ml of the tincture, add 3 drops of dilute hydrochloric acid. Bring to a
boil. After cooling, shake with 3 ml of ethyl ether. Separate the ethyl ether
phase. It has a yellow color. Shake the ethyl ether phase with 2 ml of
potassium hydroxide solution. In the ethyl ether phase a pale yellow color
is produced, and in the aqueous phase a red color is produced.
Test 3 (CHROMATOGRAPHY):
Procedure A:
Test Solution: tincture
Reference Solution: 10 mg dantron in 10 ml methanol
Plate: silica gel of suitable grade
Application: 20 µl test solution and 10 µl reference solution in 10 mm
bands
Mobile phase: toluene + ethyl acetate + anhydrous formic acid
(70+25+5)
Development: 10 cm
Drying: in air
Detection 1: Examine under ultraviolet light at 365 nm.
Result 1 Reference Solution:
· generally, an orange-tinted band at about Rf 0.85 (dantron)
 Result 1 Test Solution:
Generally,
· two blue-tinted bands at about Rf 0.40 and 0.65
· an orange-tinted band at about Rf 0.75
· an orange-tinted band at about Rf 0.85 (corresponds to dantron)
Detection 2: Spray with alcoholic 2 N potassium hydroxide solution.
Examine in daylight.
Result 2 Test Solution:
· a pink band at about Rf 0.75
· a pink band at about Rf 0.85 (corresponds to dantron)
Procedure B:
Test Solution: To 5 ml of the tincture, add 10 ml of 11% hydrochloric
acid. Boil under a reflux condenser for 15 minutes, then cool and shake
with two 15 ml portions of ethyl ether. Dry the combined organic
phases over anhydrous sodium sulfate and filter. Evaporate the filtrate
to dryness under reduced pressure and dissolve the residue in 0.5 ml
of methanol.
Reference Solution: 2 mg scopoletin, 5 mg emodin, and 10 mg dantron
in 10 ml methanol
Plate: silica gel HF254
Application: 40 µl test solution and 10 µl reference solution in 10 mm
bands
Mobile phase: toluene + ethyl acetate + anhydrous formic acid
(70+25+5)
Development: 10 cm
Drying: in air
Detection 1: Examine under ultraviolet light at 254 nm.
Result 1 Reference Solution:
· a light blue band in the lower third (scopoletin)
· a dark band in the middle third (emodin)
· a dark band at the boundary between the middle and upper thirds
(dantron)
Result 1 Test Solution:
· three dark bands running upwards to about the height of the
scopoletin band, of which the middle is the most intense
· three dark bands between the scopoletin and emodin bands
· a dark band at the height of the emodin band
· a dark band at the height of the dantron band
Detection 2: Spray with alcoholic potassium hydroxide solution.
Examine in daylight.
Result 2 Reference Solution:
· red emodin and dantron bands
Result 2 Test Solution:
· red bands at the height of the emodin and dantron bands
3. ALCOHOL CONTENT: 45% v/v (±15%) as per S & C Section - Alcohol
Determination.
4. DRY RESIDUE: not less than 1.2% w/w as per S & C Section - Dry
Residue Determination.

July, 2008

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