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REFERENCE STANDARDS | PHARMACEUTICAL
Residual Solvents
In dimethyl sulfoxide, 1 mL/ampul
cat.# 36009 (ea.)
Chloroform (67-66-3) 60 µg/mL
1,4-Dioxane (123-91-1) 380
Methylene chloride (dichloromethane)
(75-09-2) 600
Trichloroethene (79-01-6) 80
The Class 1 mixtures below reflect the requirements of USP23/
NF18 effective January 1, 1995 to December 31, 1999. While
these mixtures do not meet the current USP guidelines, many
still use these mixtures to obtain a detectable benzene peak for
the direct injection methods, Method I and Method V.
USP <467> Calibration Mix #7 (4 components)
In methanol, 1 mL/ampul
cat.# 36008 (ea.)
Chloroform (67-66-3) 60 µg/mL
1,4-Dioxane (123-91-1) 380
Methylene chloride (dichloromethane)
(75-09-2) 600
Trichloroethene (79-01-6) 80
USP <467> Calibration Mix #6 (4 components)
In dimethyl sulfoxide, 1 mL/ampul
cat.# 36007 (ea.)
Benzene (71-43-2) 2 µg/mL
Chloroform (67-66-3) 60
1,4-Dioxane (123-91-1) 380
Methylene chloride (dichloromethane)
(75-09-2) 600
Trichloroethene (79-01-6) 80
USP <467> Calibration Mixture #5 (5 components)
In methanol, 1 mL/ampul
cat.# 36006 (ea.)
Benzene (71-43-2) 2 µg/mL
Chloroform (67-66-3) 60
1,4-Dioxane (123-91-1) 380
Methylene chloride (dichloromethane)
(75-09-2) 600
Trichloroethene (79-01-6) 80
USP <467> Calibration Mixture #4 (5 components)
In dimethyl sulfoxide, 1 mL/ampul
cat.# 36004 (ea.)
Benzene (71-43-2) 100 µg/mL
Chloroform (67-66-3) 50
1,4-Dioxane (123-91-1) 100
Methylene chloride (dichloromethane)
(75-09-2) 500
Trichloroethene (79-01-6) 100
USP <467> Calibration Mixture #3 (5 components)
Residual Solvents, cont.
USP <467>, cont. European Pharmacopoeia Method
In dimethyl sulfoxide, 1 mL/ampul
cat.# 36274 (ea.)
n -Hexane (C6) (110-54-3) 290 µg/mL
Chlorobenzene (108-90-7) 360
Cyclohexane (110-82-7) 3,880
cis-1,2-Dichloroethene (156-59-2) 1,870
N,N-Dimethylformamide (68-12-2) 880
Ethylbenzene (100-41-4) 369
Methylcyclohexane (108-87-2) 1,180
Methylene chloride (dichloromethane)
(75-09-2) 600
Tetrahydrofuran (109-99-9) 720
Toluene (108-88-3) 890
Trichloroethene (79-01-6) 80
m-Xylene (108-38-3) 1,302
o-Xylene (95-47-6) 195
p-Xylene (106-42-3) 304
European Pharmacopoeia/ICH Q3C(M) Class 2 Mix A,
Revised (14 components)
Prepared in water:dimethyl sulfoxide (80:20), 1 mL/ampul
cat.# 36270 (ea.)
Acetonitrile (75-05-8) 410 µg/mL
Chloroform (67-66-3) 60
1,2-Dimethoxyethane (110-71-4) 100
N,N-Dimethylacetamide (127-19-5) 1,090
1,4-Dioxane (123-91-1) 380
2-Hexanone (591-78-6) 50
Methanol (67-56-1) 3,000
Nitromethane (75-52-5) 50
Pyridine (110-86-1) 200
Tetralin (119-64-2) 100
European Pharmacopoeia/ICH Class 2 Mix B, Revised
(10 components)
In dimethyl sulfoxide, 1 mL/ampul
cat.# 36279 (ea.)
Benzene (71-43-2) 10 mg/mL
Carbon tetrachloride (56-23-5) 20
1,2-Dichloroethane (107-06-2) 25
1,1-Dichloroethene (75-35-4) 40
1,1,1-Trichloroethane (71-55-6) 50
Residual Solvents - Class 1 (5 components)
500 µg/mL in dimethyl sulfoxide, 1 mL/ampul
cat.# 36005 (ea.)
50 mg/mL in methylene chloride, 1 mL/ampul
cat.# 30620 (ea.)
Ethylene oxide is available in other solvents and concentrations. Request your custom
formulation at
Ethylene oxide (75-21-8)
Ethylene Oxide
The test for ethylene oxide is specified in many individual drug
monographs of USP24/NF19. The limit test concentration is
currently 10 ppm. While the specific test solution and method
will vary depending on the particular drug monograph, the
solution below is suitable for most tests.
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