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Table 6 Validation of spike recovery assay for level 2 impurities using concentration at 100% of the temporary guidance limits

From: Development and validation of a headspace GC-MS method to evaluate the interconversion of impurities and the product quality of liquid hand sanitizers

 

Product A

Product B

Product C

Product D

 

Spike mixture 100%

Spike mixture 100%

Spike mixture 100%

Spike mixture 100%

1-Propanol

114

113

108

104

1-Butanol

112

111

105

102

Ethyl Acetate

111

110

102

99

3-Methyl-1-Butanol

109

108

105

104

Amyl Alcohol

107

108

104

102

Acetone

104

101

99

98

2-Butanol

113

112

105

102

Isobutanol

112

110

103

100