Ethanol.

Page 2286
Change to: Ethanol
Absolute Alcohol; Absolute Ethanol; Dehydrated Alcohol; Ethyl Alcohol

Portions of the monograph text that are IP text, and are not part of the PDG harmonized text, are marked with
symbols (⧫⧫)

CH3 OH
C2H6O Mol. Wt. 46.1

Ethanol contains not less than 99.2 per cent w/w, corresponding to not less than 99.5 per cent v/v, at 15.56°, of
ethanol C2H6O.

Category. Pharmaceutical aid (solvent).

Description. A clear, colourless, mobile, volatile liquid; has a characteristic odour and produces a burning
sensation on the tongue. Readily volatilized even at low temperatures; boils at 78°; Flammable. 

Identification

A. Determine by infrared absorption spectrophotometry (2.4.6). Compare the spectrum with that obtained with
ethanol IPRS or with reference spectrum of ethanol.

B. Specific gravity (2.4.29). (see Tests)

C. Methanol (see Related substances test). [NOTE—This test must be performed to be in compliance with IP, in
addition to Identification A and B.]

Tests

Specific gravity (2.4.29). Not more than 0.7962 at 15.56°, indicating not less than 99.2 per cent w/w of ethanol
C2H6O.

NOTE—In the event that at temperature of 15.56° cannot be reached, the Ethanol Table (2.3.45) can be used to
provide the conversion factors needed to complete this test at other temperatures.

Appearance of solution. Dilute 5.0 ml to 100.0 ml with water. Allow to stand for 5 minutes before examination.
The solution is clear (2.4.1). Cool to 10° for 30 minutes; the solution remains clear.

Colour.Test solution. The substance under examination.

Reference solution. A mixture of 3.0 ml each of, ferric chloride colorimetric solution (FCS), cobaltous chloride
colorimetric solution (CCS) and 2.4 ml of cupric sulphate colorimetric solution (CSS) and 1.6 ml of 1.0 per cent
v/v of hydrochloric acid. Dilute 1.0 ml of the solution to 100.0 ml with 1.0 per cent v/v of hydrochloric acid.

NOTE— Prepare reference solution immediately before use.

The test solution has the appearance of water or is not more intensely coloured than that of reference solution.
Use water as the blank.

Light absorption (2.4.7). When examined in the range 235 nm to 340 nm (2. 4.7), it shows an absorption
maximum at about 240 nm, not more than 0.40; between 250 nm and 260 nm, not more than 0.30 and between
270 nm and 340 nm, not more than 0.10. (Note- The spectrum shows a steadily descending curve with no
observable shoulders).

Related substances. Determine by gas chromatography (2.4.13).

Test solution (a). The substance under examination.

Test solution (b). A 0.03 per cent v/v solution of 4-methylpentan-2-ol in test solution (a).

Reference solution (a). A 0.02 per cent v/v solution of methanol in test solution (a).

Reference solution (b). A 0.1 per cent v/v solution, each of, methanol and acetaldehyde in test solution (a). Dilute
0.1ml of the solution to 10.0 ml with test solution (a).

Reference solution (c). A 0.3 per cent v/v solution of acetal in test solution (a). Dilute 0.1 ml of the solution to
10.0 ml with test solution (a).

Reference solution (d). A 0.1 per cent v/v solution of benzene in test solution (a). Dilute 0.1 ml of the solution to
50.0 ml with test solution (a).

Chromatographic system
– a capillary column 30 m x 0.32 mm, packed with 6 per cent cyanopropylphenyl and 94 per cent of dimethyl
polysiloxane (film thickness 1.8 µm), (Such as DB 624)
– temperature
column 40° for 0-12 minutes, 40° to 240° @ 10° per minutes and hold at 240° for 10 minutes.
– inlet port at 200° and detector at 280°,
– flame ionization detector,
– split ratio: 20:1,
– flow 35 cm per second, using helium as carrier gas,
– injection volume: 1 µl.

Inject reference solution (b). The test is not valid unless the resolution between the peaks due to acetaldehyde
(first peak) and methanol (second peak) is not less than 1.5.
Inject reference solution (a), (b), (c), test solution (a) and (b). In the chromatogram obtained with the test solution
(a), the area of any peak corresponding to methanol is not more than 0.5 times the area of the principal peak in
the chromatogram obtained with reference solution (a) (200 ppm) and the sum of the contents of acetaldehyde
and acetal, is not more than 10 ppm, expressed as acetaldehyde.

Calculate the contents of methanol using following expression;

Result = 𝑟𝑢 /𝑟𝑠
where,
ru = peak area of methanol from test solution (a).
rs = peak area of methanol from reference solution (a).

Calculate the sum of the contents of acetaldehyde and acetal in parts per million v/v using the following
expression:

Result = {[AE/(AT − AE)] × CA} + {[DE/(DT − DE)] × CD × (Mr1/Mr2)}

where,
AE = area of the peak due to acetaldehyde in the chromatogram obtained with test solution (a),
AT =area of the peak due to acetaldehyde in the chromatogram obtained with reference solution (b),
CA=concentration of acetaldehyde in reference solution (b) (µl/l),
DE=area of the peak due to acetal in the chromatogram obtained with test solution (a),
DT= area of the peak due to acetal in the chromatogramobtained with reference solution (c),
CD=concentration of acetal in reference solution (c) (µl/l),
Mr1= molecular weight of acetaldehyde, 44.05
Mr2= molecular weight of acetal. 118.2

Content of benzene is not more than 2 ppm v/v, calculated in parts per million v/v using the following expression

Result = [BE/(BT − BE)] × CB

where, BE= area of the peak due to benzene in the chromatogram obtained with test solution (a),
 BT=area of the peak due to benzene in the chromatogram obtained with reference solution (d).
CB = concentration of benzene in the reference solution (d), (µl/l).

NOTE—If necessary, the identity of benzene can be confirmed using another suitable chromatographic system
(stationary phase with a different polarity).

The area of any other secondary peak is not more than the area of the 4-methylpentan-2-ol in the chromatogram
obtained with test solution (b) and the sum of areas of all other secondary peaks (specified and unspecified)
obtained with test solution (b) is not more than the area of 4-methylpentan-2-ol peak in the chromatogram obtained
with test solution (b) (300 ppm). Ignore any peak with an area less than 0.03 times the area of 4-methylpentan-2-
ol peak in the chromatogram obtained with test solution (b) (9 ppm).

Acidity or alkalinity. To 20 ml of Ethanol, add 20 ml of freshly boiled and cooled water. Add 0.1 ml of
phenolphthalein solution. The solution is colourless, add 1.0 ml of 0.01M sodium hydroxide, the colour of the
solution changes to pink (30 µg per g, expressed as acetic acid).

Non-volatile residue. Evaporate 100.0 ml of Ethanol in a tared dish on a water-bath and dry the residue at 100°-
105° for 1 hour; the residue weight not more than 2.5 mg.

Storage. Store in tightly-closed containers at a temperature not exceeding 30°, away from fire and protected from
light.

Labelling. The label states that it is flammable.