Analyzing impurities in hand sanitizer

Ethanol, also known as ethyl alcohol, is one of the most commonly used volume organic chemicals utilized in the manufacture of consumer products, including personal care products and household cleaners.

It is also an essential chemical when used in industrial products such as printing inks and adhesives, as well as sanitizers which have become central to the daily sanitation needs of humans around the world.

It is crucial that the quality of ethanol used in these products is carefully monitored to protect human and animal health. This article presents an analysis of trace level impurities that could be found in ethanol as per the United States Pharmacopeia (USP) guideline.

Firstly, the analysis of USP grade Ethanol is described in accordance with USP recommended conditions and procedures. The second section details a procedure that has been modified to generate excellent results with a significant improvement in data throughput and a considerable reduction in laboratory sample preparation time.

Instrumentation

The PerkinElmer Clarus® 690 GC with built-in autosampler was used to carry out these experiments. Configuration of the Clarus 690 GC was in arrangement with a capillary injector and dual flame ionization detector (FID), which possesses an extensive range.

Installation of a PerkinElmer Elite 624 and BAC-1 columns was positioned in the injector via a two-hole ferrule or a “Y” splitter as displayed in Figure 1. The GC conditions necessary for the analysis are detailed in Table 1.

30 m 0.32 mm Elite 624 and Elite-BAC columns used in this study.

Figure 1. 30 m 0.32 mm Elite 624 and Elite-BAC columns used in this study. Image Credit: PerkinElmer

Experimental

The GC conditions can be seen in Table 1.

Chromatography conditions

Table 1. Chromatography conditions. Source: PerkinElmer

GC Parameters
Instrument PerkinElmer Clarus 690 GC
Carrier Gas Helium
Columns Elite-624 30 m 0.32 mm 1.8 μm N9316203
Elite-BAC1 30 m 0.32 mm 1.8 μm N9315071
Column Pneumatics Flow: 1 mL/minute Split: 50 mL/min
Autosampler Parameters
Syringe Size 5 μL
Injection Volume 1 μL
Injection Speed Normal
# of Plunges 8 times
Pre-washes 4
Sample Washes 2
Post Washes 2
Viscosity 5
Injector Parameters
Injector Type: S/S Temp: 240 °C
Detector Parameters
Type FID
Temperature 300 °C
Range 1
Att -6
Hydrogen 30 mL/min
Air 450 mL/min
Data Rate 12.5 pt/sec
Oven Parameters
Oven Initial Temperature 40 °C
Oven Initial Hold 5 minutes
Ramp Rate 30 °C/minute
Final Temperature 240 °C
Final Time 4 minutes
Oven Maximum 260 °C
Equilibration Time 0

 

Data acquisition

Data acquisition and data processing were conducted with the TotalChrom™ chromatography data system (CDS) software.

Sample preparation

An aliquot of the Ethanol sample was introduced to a 2 mL autosampler vial and arranged in place in the integrated autosampler of the Clarus 690 Gas Chromatograph (GC).

Standard preparation:

Table 2. Preparation of standards. Source: PerkinElmer

Impurity Std Conc. Desired Conc.PPM Final Vol. Amt. Used μL
Acetone 999000 4400 25 110
1-propanol 999000 1000 25 25
Ethyl Acetate 999000 2200 25 55
2-butanol 999000 6200 25 155
IsoButanol 999000 21700 25 543
1- butanol 999000 1000 25 25
1-methyl-1- butanol 999000 4100 25 102.6
Amyl Alcohol 999000 4100 25 102.6

 

10 mL of ethanol was used to dilute 0.3 mL of the above standard for running in the GC system.

Results and discussion

Impurity standard using 624 column.

Figure 2. Impurity standard using 624 column. Image Credit: PerkinElmer

Impurity standard using BAC column.

Figure 3. Impurity standard using BAC column. Image Credit: PerkinElmer

Table 3. Impurities %RSD of Ethanol and IPA standards. Source: PerkinElmer

Ethanol G43
Column
Confirmatory
Column
Isopropanol G43
Column
Compound Precision
% RS
Precision
% RSD
Compound Precision
% RSD
Acetaldehyde 0.78 1.18 Ethyl Ether 1.95
Methanol 1.17 1.25 Acetone 1.69
Benzene 1.32 1.07 Diisopropyl 1.42
Acetal 0.97 1.03 1-Propanol 1.33
4-Methyl-2-Pentanol 0.92 0.96 2-Butanol 1.31

 

Summary

It has been shown that utilizing both a G43 (624) and BAC-1 as the confirmation column demonstrates an excellent %RSD of impurities found in hand sanitizers. A rapid 10 minute analytical run time facilitates maximum laboratory productivity.

Stacked plot of standard and three locally purchased hand sanitizers.

Stacked plot of standard and three locally purchased hand sanitizers.

Stacked plot of standard and three locally purchased hand sanitizers.

Stacked plot of standard and three locally purchased hand sanitizers.

Figure 4. Stacked plot of standard and three locally purchased hand sanitizers. Image Credit: PerkinElmer

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Last updated: Feb 28, 2022 at 9:03 AM

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