AOAC CASP Meeting

102 103 104 105 106 107 108 109 110

U.S. Food and Drug Administration: Bioanalytical Method Validation Guidance for Industry, May

2018

9. Maximum Time-To-Result: None

Table 1: Residual Solvents

Table 1: List of Residual Solvents and Targeted LOQs

Analytical Range Lower (≤ ppm) Upper (ppm)

Proposed Target LOQ (ppm)

Concentration Limit (ppm)

Class 1 Residual Solvents* Benzene

2 4 5

2 4 5

60

1 2

120 150

Carbon tetrachloride 1,2-Dichloroethane

2.5

8

8

240

1,1-Dichloroethene

4

1500

1500

45000

1,1,1-Trichloroethane

750

Class 2 Residual Solvents*

6

180

acetonitrile

6

3

360

10800

Chlorobenzene

360

180

60 70

1800 2100

Chloroform

60 70

30 35

Cumene

3880 1870

116400

Cyclohexane

3880 1870

1940

56100

1,2-Dichloroethene 1,2-Dimethoxyethane N,N-Dimethylacetamide N,N-Dimethylformamide

935

100

3000

100

50

1090

32700 26400 11400

1090

545 440 190 310 110 145 80

880 380 160 620 220 290

880 380 160 620 220 290

1,4-Dioxane

4800

2-Ethoxyethanol Ethylene glycol

18600

6600 8700

Formamide

Hexane

n-hexane

60

400

1200 1500

Methanol

400

200

50

2-Methoxyethanol

50

25