528
REFERENCE STANDARDS|
PHARMACEUTICAL MATERIALS
USP, European Pharmacopoeia
benzene
2µg/mL
carbon tetrachloride
4
1,2-dichloroethane
5
1,1-dichloroethene
8
1,1,1-trichloroethane
1500
European Pharmacopoeia/ICH Class 1 Mix
(5 components)
Prepared in water:dimethyl sulfoxide (90:10), 1mL/ampul
cat. # 36228 (ea.)
European Pharmacopoeia Method
The analysis of residual solvents in pharmaceutical products has
changed, particularly for products being sold into Europe. The
International Conference on Harmonization (ICH)
Guidelines
for Residual Solvents
is becoming the international standard and
is being adopted by more pharmacopoeias, including the United
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-
ceutical manufacturing. Use of Class 2 compounds is to be lim-
ited, as they pose a lower, but present, threat to health.
Compounds in Class 3 pose the lowest toxic potential and may
be used routinely in manufacturing.
benzene
2µg/mL
carbon tetrachloride
4
1,2-dichloroethane
5
1,1-dichloroethene
8
1,1,1-trichloroethane
10
European Pharmacopoeia/ICH Class 1 Mix (revised)
(5 components)
In water:dimethyl sulfoxide (90:10), 1mL/ampul
cat. # 36261 (ea.)
These Class 1 mixtures reflect the changes made in USP24/NF19
effective January 1, 2000, and USP23/NF18 effective January 1,
1995 to December 31, 1999. While these mixtures do not meet
the current USP guidelines, many labs still use these mixtures to
obtain a detectable benzene peak for the direct injection meth-
ods, Method I and Method V.
chloroform
60µg/mL
1,4-dioxane
380
methylene chloride
600
trichloroethene
80
USP <467> Calibration Mix #6
(4 components)
In methanol, 1mL/ampul
cat. # 36008 (ea.)
chloroform
60µg/mL
1,4-dioxane
380
methylene chloride
600
trichloroethene
80
USP <467> Calibration Mix #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> Calibration Mixture #4
(5 components)
In methanol, 1mL/ampul
cat. # 36006 (ea.)
benzene
2µg/mL
chloroform
60
1,4-dioxane
380
methylene chloride
600
trichloroethene
80
USP <467> Calibration Mixture #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> Calibration Mixture #2
(5 components)
In methanol, 1mL/ampul
cat. # 36002 (ea.)
benzene
100µg/mL
chloroform
50
1,4-dioxane
100
methylene chloride
500
trichloroethene
100
USP <467> Calibration Mixture #3
(5 components)
In dimethyl sulfoxide, 1mL/ampul
cat. # 36004 (ea.)
Ethylene oxide is available in other solvents and concentrations. Request your
custom formulation at
.
Ethylene Oxide
500µg/mL in dimethyl sulfoxide, 1mL/ampul
cat. # 36005 (ea.)
USP <467>
cont'd
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Solutions Online
diethylene glycol 0.5mg/mL
ethylene glycol
0.5
glycerin
20
Glycerin Standard Mix
(3 components)
In P&T methanol, 1mL/ampul
cat. # 31891 (ea.)
Limit of Diethylene & Ethylene Glycol 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 raw material for the presence of dieth-
ylene glycol. Under cGMPs, drug manufacturers—not just
glycerin manufacturers—must now test glycerin prior to use to
prevent DEG-contamination in finished products. FDA has
worked extensively with USP to modify the glycerin monograph
and these standards support the revised USP method.
diethylene glycol 0.5mg/mL
ethylene glycol
0.5
propylene glycol
20
Propylene Glycol Standard Mix
(3 components)
In P&T methanol, 1mL/ampul
cat. # 31892 (ea.)
diethylene glycol
ethylene glycol
Sorbitol Standard Mix
(2 components)
0.8mg/mL each in acetone:water (90:10), 1mL/ampul
cat. # 31893 (ea.)
2,2,2-trichloroethanol
Limit of Diethylene & Ethylene Glycol Internal Standard Mix
10mg/mL in P&T methanol, 1mL/ampul
cat. # 31894 (ea.)
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