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Table 5 Validation of spike recovery assay for active ingredients and level 1 impurities using concentrations at 50%, 100%, and 200% 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

 

Spike mixture 50%

Spike mixture 100%

Spike mixture 200%

Spike mixture 50%

Spike mixture 100%

Spike mixture 200%

Ethanol

95

90

94

106

100

91

Isopropanol

104

97

101

105

103

99

Benzene

85

86

88

93

97

96

Acetaldehyde

88

94

96

101

94

95

Acetal

84

90

92

105

90

104

Methanol

92

99

97

89

96

94

 

Product C

Product D

 

Spike mixture 50%

Spike mixture 100%

Spike mixture 200%

Spike mixture 50%

Spike mixture 100%

Spike mixture 200%

Ethanol

102

98

103

103

101

100

Isopropanol

93

86

94

93

92

89

Benzene

107

106

104

100

100

102

Acetaldehyde

94

95

97

94

97

97

Acetal

108

105

108

110

107

109

Methanol

97

100

100

96

98

99