Restek 2011/12 Chromatography Catalog - page 527

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REFERENCE STANDARDS | PHARMACEUTICAL MATERIALS
USP
USP <467>
acetonitrile 2.05mg/mL
chlorobenzene 1.80
cyclohexane 19.40
cis-1,2-dichloroethene 4.70
trans-1,2-dichloroethene 4.70
1,4-dioxane 1.90
ethylbenzene 1.84
methanol 15.00
methylcyclohexane 5.90
methylene chloride 3.00
tetrahydrofuran 3.45
toluene 4.45
m-xylene 6.51
o-xylene 0.98
p-xylene 1.52
Residual Solvents Class 2 - Mix A (15 components)
In dimethyl sulfoxide, 1mL/ampul
cat. # 36271 (ea.)
2-ethoxyethanol 800µg/mL
ethylene glycol 3,100
formamide 1,100
N,N-dimethylacetamide 5,450
N,N-dimethylformamide 4,400
2-methoxyethanol
(methyl Cellosolve) 250
N-methylpyrrolidone 2,650
sulfolane 800
Residual Solvents Class 2 - Mix C (8 components)
In dimethyl sulfoxide, 1mL/ampul
cat. # 36273 (ea.)
Compound Solvent Conc. cat.# (ea.) price
acetonitrile DMSO 2.05mg/mL 36281
benzene DMSO 10mg/mL 36282
carbon tetrachloride DMSO 20mg/mL 36283
chlorobenzene DMSO 1.8mg/mL 36284
chloroform DMSO 0.3mg/mL 36285
cyclohexane DMSO 19.4mg/mL 36286
1,1-dichloroethene DMSO 40mg/mL 36287
1,2-dichloroethane DMSO 25mg/mL 36288
cis-1,2-dichloroethylene DMSO 4.67mg/mL 36289
trans-1,2-dichloroethylene DMSO 4.67mg/mL 36290
1,2-dimethoxyethane DMSO 0.5mg/mL 36291
N,N-dimethylacetamide DMSO 5.45mg/mL 36292
N,N-dimethylformamide DMSO 4.4mg/mL 36293
1,4-dioxane DMSO 1.9mg/mL 36294
2-ethoxyethanol DMSO 0.8mg/mL 36295
ethylbenzene DMSO 1.84mg/mL 36296
ethylene glycol DMSO 3.1mg/mL 36297
formamide DMSO 1.1mg/mL 36298
hexane DMSO 1.45mg/mL 36299
methanol DMSO 15mg/mL 36401
2-methoxyethanol DMSO 0.25mg/mL 36402
methylbutylketone DMSO 0.25mg/mL 36400
methylcyclohexane DMSO 5.9mg/mL 36403
methylene chloride (dichloromethane) DMSO 3mg/mL 36404
N-methylpyrrolidone DMSO 2.65mg/mL 36405
nitromethane DMSO 0.25mg/mL 36406
pyridine DMSO 1mg/mL 36407
sulfolane DMSO 0.8mg/mL 36413
tetrahydrofuran (THF) DMSO 3.6mg/mL 36408
tetralin DMSO 0.5mg/mL 36409
toluene DMSO 4.45mg/mL 36410
1,1,1-trichloroethane DMSO 50mg/mL 36411
trichloroethene DMSO 0.4mg/mL 36412
m-xylene DMSO 6.51mg/mL 36414
o-xylene DMSO 0.97mg/mL 36415
p-xylene DMSO 1.52mg/mL 36416
DMSO = dimethyl sulfoxide
USP <467> Singles
Volume is 1mL/ampul.
benzene 10mg/mL
carbon tetrachloride 20
1,2-dichloroethane 25
1,1-dichloroethene 40
1,1,1-trichloroethane 50
Residual Solvents - Class 1 (5 components)
In dimethyl sulfoxide, 1mL/ampul
cat. # 36279 (ea.)
chloroform 60µg/mL
1,2-dimethoxyethane 100
n-hexane (C6) 290
2-hexanone 50
nitromethane 50
pyridine 200
tetralin 100
trichloroethene 80
Residual Solvents Class 2 - Mix B (8 components)
In dimethyl sulfoxide, 1mL/ampul
cat. # 36280 (ea.)
free literature
Residual Solvent Analysis
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Flyer
lit. cat.# PHFL1018A
These mixtures reflect the changes made in USP30/NF25
effective July 1, 2008.
OVI retention index
For a list of OVI retention times, see pages 693 and 696.
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 substances, drug products, and excipients. In an attempt to better mirror the
International Conference on Harmonization (ICH) guidelines, the USP has adopted a more comprehensive methodology 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 toxicity. 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.
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