Restek-2015

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REFERENCE 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.