Restek Reference Standards 11/12 - page 91

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REFERENCESTANDARDS| PHARMACEUTICALMATERIALS
USP, European Pharmacopoeia
benzene 2µg/mL
carbon tetrachloride 4
1,2-dichloroethane 5
1,1-dichloroethene 8
1,1,1-trichloroethane 1500
EuropeanPharmacopoeia/ICHClass1Mix (5 components)
Prepared inwater:dimethyl sulfoxide (90:10), 1mL/ampul
cat.# 36228 (ea.)
EuropeanPharmacopoeiaMethod
The analysis of residual solvents inpharmaceutical products has
changed, particularly for products being sold into Europe. The
International Conference onHarmonization (ICH) Guidelines
forResidual Solventsisbecoming the international standardand
isbeingadoptedbymorepharmacopoeias, including theUnited
States Pharmacopeia, every year. The ICH method and com-
pound list is more extensive than any method previously used
and poses new challenges. Compounds in Class 1 are solvents
considered to be of highest risk and to be avoided in pharma-
ceuticalmanufacturing.Use of Class 2 compounds is tobe lim-
ited, as they pose a lower, but present, threat to health.
Compounds inClass 3 pose the lowest toxic potential andmay
beused routinely inmanufacturing.
benzene 2µg/mL
carbon tetrachloride 4
1,2-dichloroethane 5
1,1-dichloroethene 8
1,1,1-trichloroethane 10
EuropeanPharmacopoeia/ICHClass1Mix (revised)
(5 components)
Inwater:dimethyl sulfoxide (90:10), 1mL/ampul
cat.# 36261 (ea.)
TheseClass 1mixtures reflect the changesmade inUSP24/NF19
effective January 1, 2000, andUSP23/NF18 effective January 1,
1995 toDecember 31, 1999.While thesemixtures do not meet
thecurrentUSP guidelines,many labs still use thesemixtures to
obtain a detectable benzene peak for the direct injectionmeth-
ods,Method I andMethodV.
chloroform 60µg/mL
1,4-dioxane 380
methylene chloride 600
trichloroethene 80
USP<467>CalibrationMix#6 (4 components)
Inmethanol, 1mL/ampul
cat.# 36008 (ea.)
chloroform 60µg/mL
1,4-dioxane 380
methylene chloride 600
trichloroethene 80
USP<467>CalibrationMix#7 (4 components)
In dimethyl sulfoxide, 1mL/ampul
cat.# 36009 (ea.)
benzene 2µg/mL
chloroform 60
1,4-dioxane 380
methylene chloride 600
trichloroethene 80
USP<467>CalibrationMixture#4 (5 components)
Inmethanol, 1mL/ampul
cat.# 36006 (ea.)
benzene 2µg/mL
chloroform 60
1,4-dioxane 380
methylene chloride 600
trichloroethene 80
USP<467>CalibrationMixture#5 (5 components)
In dimethyl sulfoxide, 1mL/ampul
cat.# 36007 (ea.)
benzene 100µg/mL
chloroform 50
1,4-dioxane 100
methylene chloride 500
trichloroethene 100
USP<467>CalibrationMixture#2 (5 components)
Inmethanol, 1mL/ampul
cat.# 36002 (ea.)
benzene 100µg/mL
chloroform 50
1,4-dioxane 100
methylene chloride 500
trichloroethene 100
USP<467>CalibrationMixture#3 (5 components)
In dimethyl sulfoxide, 1mL/ampul
cat.# 36004 (ea.)
Ethylene oxide is available in other solvents and concentrations. Request your
custom formulation atstandards@restek.com.
EthyleneOxide
500µg/mL in dimethyl sulfoxide, 1mL/ampul
cat.# 36005 (ea.)
USP<467> cont'd
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diethylene glycol 0.5mg/mL
ethylene glycol 0.5
glycerin 20
GlycerinStandardMix (3 components)
In P&Tmethanol, 1mL/ampul
cat.# 31891 (ea.)
LimitofDiethylene&EthyleneGlycol Standards
Meet new FDA Guidance for Industry: Testing of Glycerin for
Diethylene Glycol with our new diethylene glycol (DEG) and
ethylene glycol limit standards. This Guidance emphasizes the
importance of screening rawmaterial for the presence of dieth-
ylene glycol. Under cGMPs, drug manufacturers—not just
glycerinmanufacturers—must now test glycerin prior to use to
prevent DEG-contamination in finished products. FDA has
worked extensivelywithUSP tomodify the glycerinmonograph
and these standards support the revisedUSPmethod.
diethylene glycol 0.5mg/mL
ethylene glycol 0.5
propylene glycol 20
PropyleneGlycolStandardMix (3 components)
In P&Tmethanol, 1mL/ampul
cat.# 31892 (ea.)
diethylene glycol ethylene glycol
SorbitolStandardMix (2 components)
0.8mg/mL each in acetone:water (90:10), 1mL/ampul
cat.# 31893 (ea.)
2,2,2-trichloroethanol
LimitofDiethylene&EthyleneGlycol InternalStandardMix
10mg/mL in P&Tmethanol, 1mL/ampul
cat.# 31894 (ea.)
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