Quality control methods for


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Dichloromethane R. Methylene chloride, CH
2
Cl
2
.
Description. A clear colourless, mobile liquid. 
Miscibility. Freely miscible with ethanol (∼750g/l) TS and ether R.
Boiling range. Not less than 95% distils between 39 and 41°C. 
Residue on evaporation. After evaporation on a water-bath and drying at 105°C, 
leaves not more than 0.5 mg/ml. 
A suitable commercially available reagent. 
Dimethyl sulfoxide R. C
2
H
6
OS. 
Description. A colourless liquid; odourless or with a slight unpleasant odour. 
Mass density (ρ
20
). 1.10kg/l. 
A suitable commercially available reagent. 
Dimethyl yellow R. C.I. 11020; 4-dimethylaminoazobenzene; C
14
H
15
N
3
.
Caution. Dimethyl yellow R is carcinogenic. 
Description. Produces a red colour in moderately acidic alcoholic solutions and 
yellow colour in weakly acidic and alkaline solutions. 
Homogeneity. Carry out the method for thin-layer chromatography, using silica 
gel G as the coating substance and dichloromethane R as the mobile phase. 
Apply 10 µl of a 0.1 mg/ml solution in dichloromethane R. After removing the 
plate from the chromatographic chamber allow it to dry in air. Only one spot 
appears on the chromatogram. 


Quality control methods for medicinal plant materials 
A suitable commercially available reagent. 
Dioxan R. 1,4-Dioxane, C
4
H
8
O
2

Caution. It is dangerous to determine the boiling range or the residue on 
evaporation before ensuring that the reagent complies with the test for 
peroxides, described below. 
Description. A clear, colourless liquid. 
Miscibility. Miscible with water, ethanol (∼750g/l) TS and ether R.
Boiling range. Not less than 95% distils between 101 and 105°C.
Melting temperature. Solidifies when cooled in ice and does not completely remelt 
at temperatures below 10°C. 
Residue on evaporation. Evaporate on a water-bath and dry to than constant 
weight at 105°C; leaves a residue of not more than 0.1 mg/ml. 
Mass density (ρ
20
). About 1.031 kg/l. 
Water. Determined by the Karl Fischer method, not more than 5.0 mg/ml. 
Peroxides. Add 5 ml to a mixture of 1 g of potassium iodide R dissolved in 10ml 
of water, 5 ml of hydrochloric acid (∼70 g/l) TS, and 2 ml of starch TS, and mix; 
not more than a faint blue or brown colour is produced. 
A suitable commercially available reagent. 

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