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www.restek.comREFERENCE STANDARDS |
PHARMACEUTICAL
Residual Solvents
USP <467> Singles
Volume is 1 mL/ampul.
Compound
CAS # Solvent
Conc.
cat.#
price
acetonitrile
75-05-8 DMSO 2.05 mg/mL 36281
benzene
71-43-2 DMSO 10 mg/mL 36282
carbon tetrachloride
56-23-5 DMSO 20 mg/mL 36283
chlorobenzene
108-90-7 DMSO 1.8 mg/mL 36284
chloroform
67-66-3 DMSO 0.3 mg/mL 36285
cyclohexane
110-82-7 DMSO 19.4 mg/mL 36286
1,1-dichloroethene
75-35-4 DMSO 40 mg/mL 36287
1,2-dichloroethane
107-06-2 DMSO 25 mg/mL 36288
cis
-1,2-dichloroethylene
156-59-2 DMSO 4.67 mg/mL 36289
trans
-1,2-dichloroethylene
156-60-5 DMSO 4.67 mg/mL 36290
1,2-dimethoxyethane
110-71-4 DMSO 0.5 mg/mL 36291
N,N-dimethylacetamide
127-19-5 DMSO 5.45 mg/mL 36292
N,N-dimethylformamide
68-12-2 DMSO 4.4 mg/mL 36293
1,4-dioxane
123-91-1 DMSO 1.9 mg/mL 36294
2-ethoxyethanol
110-80-5 DMSO 0.8 mg/mL 36295
ethylbenzene
100-41-4 DMSO 1.84 mg/mL 36296
ethylene glycol
3775-85-7 DMSO 3.1 mg/mL 36297
formamide
75-12-7 DMSO 1.1 mg/mL 36298
hexane
8031-34-3 DMSO 1.45 mg/mL 36299
methanol
67-56-1 DMSO 15 mg/mL 36401
2-methoxyethanol
109-86-4 DMSO 0.25 mg/mL 36402
methylbutylketone
591-78-6 DMSO 0.25 mg/mL 36400
methylcyclohexane
108-87-2 DMSO 5.9 mg/mL 36403
methylene chloride (dichloromethane) 75-09-2 DMSO 3 mg/mL 36404
N-methylpyrrolidone
872-50-4 DMSO 2.65 mg/mL 36405
nitromethane
75-52-5 DMSO 0.25 mg/mL 36406
pyridine
110-86-1 DMSO 1 mg/mL 36407
sulfolane
126-33-0 DMSO 0.8 mg/mL 36413
tetrahydrofuran (THF)
109-99-9 DMSO 3.6 mg/mL 36408
tetralin
119-64-2 DMSO 0.5 mg/mL 36409
toluene
108-88-3 DMSO 4.45 mg/mL 36410
1,1,1-trichloroethane
71-55-6 DMSO 50 mg/mL 36411
trichloroethene
79-01-6 DMSO 0.4 mg/mL 36412
m
-xylene
108-38-3 DMSO 6.51 mg/mL 36414
o
-xylene
95-47-6 DMSO 0.97 mg/mL 36415
p
-xylene
106-42-3 DMSO 1.52 mg/mL 36416
DMSO = dimethyl sulfoxide
Residual Solvents
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
These mixtures reflect the changes made in USP30/NF25
effective July 1, 2008.
Residual Solvents - Class 1
(5 components)
In dimethyl sulfoxide, 1 mL/ampul
cat.# 36271 (ea.)
Acetonitrile (75-05-8)
2.05 mg/mL
Chlorobenzene (108-90-7)
1.80
Cyclohexane (110-82-7)
19.40
cis
-1,2-Dichloroethene (156-59-2) 4.70
trans
-1,2-Dichloroethene
(156-60-5)
4.70
1,4-Dioxane (123-91-1)
1.90
Ethylbenzene (100-41-4)
1.84
Methanol (67-56-1)
15.00
Methylcyclohexane (108-87-2)
5.90
Methylene chloride (dichloromethane)
(75-09-2)
3.00
Tetrahydrofuran (109-99-9)
3.45
Toluene (108-88-3)
4.45
m
-Xylene (108-38-3)
6.51
o
-Xylene (95-47-6)
0.98
p
-Xylene (106-42-3)
1.52
Residual Solvents Class 2 - Mix A
(15 components)
In dimethyl sulfoxide, 1 mL/ampul
cat.# 36280 (ea.)
n
-Hexane (C6) (110-54-3)
290 µg/mL
Chloroform (67-66-3)
60
1,2-Dimethoxyethane (110-71-4)
100
2-Hexanone (591-78-6)
50
Nitromethane (75-52-5)
50
Pyridine (110-86-1)
200
Tetralin (119-64-2)
100
Trichloroethene (79-01-6)
80
Residual Solvents Class 2 - Mix B
(8 components)
In dimethyl sulfoxide, 1 mL/ampul
cat.# 36273 (ea.)
2-Ethoxyethanol (110-80-5) 800 µg/mL
Ethylene glycol (107-21-1)
3,100
Formamide (75-12-7)
1,100
N,N-Dimethylacetamide (127-19-5) 5,450
N,N-Dimethylformamide (68-12-2) 4,400
2-Methoxyethanol (Methyl Cellosolve)
(109-86-4)
250
N-Methylpyrrolidone (872-50-4) 2,650
Sulfolane (126-33-0)
800
Residual Solvents Class 2 - Mix C
(8 components)
USP <467>
In dimethyl sulfoxide, 1 mL/ampul
cat.# 36012 (ea.)
Acetonitrile (75-05-8)
2.05 mg/mL
Chlorobenzene (108-90-7)
1.8
Cyclohexane (110-82-7)
19.4
cis
-1,2-Dichloroethene (156-59-2) 4.675
trans
-1,2-Dichloroethene
(156-60-5)
4.675
1,4-Dioxane (123-91-1)
1.9
Ethylbenzene (100-41-4)
1.84
Isopropylbenzene (cumene)
(98-82-8)
0.35
Methanol (67-56-1)
15
Methylcyclohexane (108-87-2)
5.9
Methylene chloride
(dichloromethane) (75-09-2)
3
Tetrahydrofuran (109-99-9)
3.6
Toluene (108-88-3)
4.45
m
-Xylene (108-38-3)
6.51
o
-Xylene (95-47-6)
0.98
p
-Xylene (106-42-3)
1.52
Residual Solvents Class 2 - Mix A (2013 Rev)
(16 components)
The United States Pharmacopeia (USP) General Chapter <467>
Residual Solvents is a widely used compendial method intended
for identifying and quantifying residual solvents in drug sub-
stances, drug products, and excipients. In an attempt to better
mirror the International Conference on Harmonization (ICH)
guidelines, the USP has adopted a more comprehensive method-
ology in residual solvent testing—the current USP30/NF25. The
ICH publishes a guideline (Q3C) listing the acceptable amounts
of solvent residues that can be present. In the ICH guideline,
residual solvents are summarized by class according to their tox-
icity. Class 1 compounds are carcinogenic compounds that pose
a risk to both the consumer and the environment. The use of
these solvents is to be avoided, but if they are used, they must be
tightly controlled. Class 2 compounds are nongenotoxic animal
carcinogens, and concentrations of these compounds should
be limited. Chromatographic analysis is needed for both the
Class 1 and Class 2 residual solvents.
This mixture reflects the changes made in USP <467> effective
August 2013 and replaces Restek® cat.# 36271.
NEW!
Note: The USP <467> Class 2 residual solvents list was updated
to add cumene in August 2013. See cat.# 36012 (above) for our
updated reference standard.