Page 5 - Application Notebook - Hand Sanitizer Analysis

Application No. G331
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 Analysis of Volatile Impurities
Methanol, acetaldehyde, acetal and benzene are analyzed to verify that the volumes of these impurities will not exceed
those specified. The chromatograms of the samples (i.e. anhydrous ethanol and ethanol for disinfection), the sample
solution and standard solutions (1) – (4) are shown in Fig.3 and Fig. 4. The peak areas and volumes of the volatile
impurities are listed in Table 2. The data obtained were confirmedto meet the three purity criteria listed below.
1. The peak area of methanol obtained with the sample be no greater than 1/2 times that of methanol with the standard
solution (1).
2. When calculating the amounts of the volatile impurities, the total amount of acetaldehyde and acetal (equation 1) be no
more than 10 vol ppm as acetaldehyde and the amount of benzene (equation 2) be no more than 2 vol ppm.
*1
3. The total area of all other impurities peak with the sample solution be no larger than the peak area of 4-methylpentan2-ol .
30 × C E × 44.05
10 × A E
アセトアルデヒド及びアセタールの量の和（vol ppm）=
(Equation 1)
Total amount of acetaldehyde and acetal (vol ppm) + （式1） ＊2 *2
(C T – C E ) × 118.2
A T ー A E
*1: Peaks with areas less than 3 % of that of 4-methyl-2-pentanol
2B E
（式2）
ベンゼンの量（vol ppm）=
Amount of benzene (vol ppm) (Equation 2) should not be included. In this experiment, no target peaks
B T - B E
were detected in the sample solution.
*2: For abbreviations of A , B , C , A , C and B , see refer to Table 2.
E
E
T
E
T
T
無水エタノールnol
Acetaldehyde Methanol 4-Methylpentane-2-ol uV Anhydrous etha
Sample solution (spiked with 4-Methylpentane-2-ol)
試料溶液（4-Methylpentane-2-ol 添加）
a
S
標準溶液（1）ion (1)
t
n
s
o
r

d
d
t
u
a
l
Standard solution (2)
標準溶液（2）
標準溶液（3）
Standard solution (3)
標準溶液（4）
Standard solution (4)
SN比io 11.7
Benzene Acetal Benzene SN rat 11.7
0.0 2.5 5.0 7.5 10.0 12.5 15.0 17.5 min 9.5 10.0 10.5 11.0 min
Fig. 3 Chromatograms of Anhydrous Ethanol, Sample Solution and Standard Solutions (1) – (4)
Ethanol for disinfection
消毒用エタノール
Acetaldehyde Methanol 4-Methylpentane-2-ol uV Standard solut
試料溶液（4-Methylpentane-2-ol 添加）
Sample solution (spiked with 4-methylpentane-2-ol)
標準溶液（1）ion (1)
Standard solut
標準溶液（2）ion (2)
標準溶液（3）ion (3)
Standard solut
標準溶液（4）
Standard solution (4)
9.3
SN比
Benzene Acetal Benzene SN ratio 9.3
0
0.0 2.5 5.0 7.5 10.0 12.5 15.0 17.5 min 9.5 10.0 10.5 11.0 min
Fig. 4 Chromatograms of Ethanol for disinfection, Sample Solution and Standard Solutions (1) – (4)
Table 2 Average Areas and Amounts of Volatile Impurities (n=3)  Conclusion
Sample
Peak area of Peak area of Peak area of Peak area of System suitability test and analysis of volatile
methanol acetaldehyde acetal benzene
Sample name A E C E B E impurities were carried out in accordance with the
Anhydrous ethanol 0 107 0 0 purity test of ethanol in the JP (USP, EP) using Nexis TM
Ethanol for 0 107 0 0
disinfection GC-2030 gas chromatograph.
Standard solution (1) Standard solution (2) Standard solution (3) Standard solution (4)
Peak area of Peak area of Peak area Peak area of The results met the criteria set for testing anhydrous
Diluted sample methanol acetaldehyde of acetal benzene
name A T C T B T ethanol and ethanol for disinfection.
Anhydrous ethanol 37050 1559 9418 1206 Nexis TM GC-2030 equipped with highly sensitive FID-
Ethanol for
disinfection 34838 3108 8863 1115 2030 had enough sensitivity to detect even the most
Total amount of acetaldehyde and acetal Amount of benzene
Sample name (vol ppm) (vol ppm) demanding volatile impurity like benzene.
Anhydrous ethanol 0.73 0
Ethanol for
disinfection 0.36 0
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First Edition: Jul. 2020
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