Restek 2011/12 Chromatography Catalog - page 529

www.restek.com 529
REFERENCE STANDARDS | PHARMACEUTICAL MATERIALS
European Pharmacopoeia, Fatty Acids, ASTM Methods
ASTM Method D6042-96 (Plastic Container Testing)
BHT
erucamide slip
vitamin E
Irgafos 168
Irganox 3114
Irganox 1010
Irganox 1076
ASTM D6042-96 Calibration Mix (7 components)
50µg/mL each in isopropanol, 1mL/ampul
cat. # 31628 (ea.)
Tinuvin P
ASTM D6042-96 Internal Standard Mix
51.8µg/mL in isopropanol, 1mL/ampul
cat. # 31629 (ea.)
No data pack available.
No data pack available.
Other Additives—Available from Restek as Custom
Formulations
Similar methods for extractables in plastic pharmaceutical containers are cited in
the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European
Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP). Customers may also
have formulation-specific or product-specific test mixtures. Please contact us for
a custom mixture. Our current inventory of raw materials includes these popular
antioxidants. We have many more not listed and can obtain most compounds you
may need.
• Ethanox 323
• Ethanox 330
• Ethanox 702
• Ethanox 703
• Irganox L06
• Irganox L57
• Irganox L64
• Irganox L109
• Irganox L134
• Irganox L135
• Irganox 1035
• Santanox R
• Ultranox 626
• Vanlube 81
• Vanlube 848
• Vanlube 7723
• Vanlube AZ
• Vanlube NA
• Vanlube PCX
• Vanlube SL
• Vanlube SS
chlorobenzene 360µg/mL
cyclohexane 3,880
cis-1,2-dichloroethene 1,870
N,N-dimethylformamide 880
ethylbenzene 369
n-hexane (C6) 290
methylcyclohexane 1,180
methylene chloride 600
tetrahydrofuran 720
toluene 890
trichloroethene 80
m-xylene 1,302
o-xylene 195
p-xylene 304
European Pharmacopoeia/ICH Q3C(M) Class 2 Mix A, Revised
(14 components)
In dimethyl sulfoxide, 1mL/ampul
cat. # 36274 (ea.)
2-ethoxyethanol 160µg/mL
ethylene glycol 620
formamide 220
2-methoxyethanol
(methyl Cellosolve) 50
N-methylpyrrolidone 530
sulfolane 160
European Pharmacopoeia/ICH Q3C(M) Class 2 Mix C, Revised
(6 components)
In dimethyl sulfoxide, 1mL/ampul
cat. # 36275 (ea.)
acetonitrile 410µg/mL
chloroform 60
1,2-dimethoxyethane 100
N,N-dimethylacetamide 1,090
1,4-dioxane 380
2-hexanone 50
methanol 3,000
nitromethane 50
pyridine 200
tetralin 100
European Pharmacopoeia/ICH Class 2 Mix B, Revised
(10 components)
Prepared in water:dimethyl sulfoxide (80:20), 1mL/ampul
cat. # 36270 (ea.)
Description % by Weight
methyl arachidate (C20:0) 40
methyl dodecanoate (C12:0) 5
methyl myristate (C14:0) 5
Description % by Weight
methyl oleate (C18:1[ cis9]) 20
methyl palmitate (C16:0) 10
methyl stearate (C18:0) 20
No data pack available.
Quantity discounts not available.
EP 2.4.22 Composition of Fatty Acids by GC Mix 1
(6 components)
100mg total
cat. # 35100 (ea.)
Description % by Weight
methyl caproate (C6:0) 10
methyl caprylate (C8:0) 10
methyl decanoate (C10:0) 20
Description % by Weight
methyl dodecanoate (C12:0) 20
methyl myristate (C14:0) 40
No data pack available.
Quantity discounts not available.
EP 2.4.22 Composition of Fatty Acids by GC Mix 2
(5 components)
100mg total
cat. # 35101 (ea.)
European Pharmacopoeia Method cont'd
NEW!
NEW!
American Society for Testing and Materials (ASTM International)
Method D6042-96— Test Method for Determination of Phenolic
Antioxidants and Erucamide Slip Additives in Polypropylene
Homopolymer Formulations Using Liquid Chromatography—
is a “consensus” or “referee” method used among plastic manu-
facturers and the pharmaceutical companies that purchase plas-
tic containers. Plastic container manufacturers use this test to
ensure the quality of their product to their pharmaceutical
customers. Pharmaceutical companies also specify this test and
provide their own lists of target compounds and concentration
limits in purchase agreements.
This test calls for isopropanol extraction, HPLC separation, and
UV detection. Restek offers a variety of reversed phase HPLC
columns suitable for these separations. Restek also designed an
analytical reference material to validate this method. This mix-
ture contains the common antioxidants and slips listed in ASTM
D6042-96, along with BHT.
NEW!
Keep up with advances in melamine
analysis at www.restek.com/melamine
Melamine Analysis Kit .........cat. # 33254
(see page 535)
Detect melamine and related compounds by
GC/MS with a complete analysis kit. Consistent
with FDA procedure and new guidance for
at-risk pharmaceutical components.
At Risk for Melamine
Meet new FDA guidance for
melamine contamination in at-risk
pharmaceutical components.
Composition of Fatty Acids by GC
Website :www.chromtech.net.auE-mail :info@chromtech.net.auTelNo : 03 9762 2034 . . . in AUSTRALIA Mar 2011