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REFERENCE STANDARDS | PHARMACEUTICAL
Diethylene & Ethylene Glycol, Fatty Acids, Pharmaceutical Compounds, Plastic Container Testing
Fatty Acids
Composition of Fatty Acids by GC
In P&T methanol, 1 mL/ampul
cat.# 31891 (ea.)
Diethylene glycol (111-46-6) 0.5 mg/mL
Ethylene glycol (107-21-1) 0.5
Glycerin (56-81-5) 20
Meet FDA Guidance for Industry: Testing of Glycerin for
Diethylene Glycol with our diethylene glycol (DEG) and ethyl-
ene glycol limit standards. This guidance emphasizes the impor-
tance of screening raw material for the presence of diethylene
glycol. Under cGMPs, drug manufacturers—not just glycerin
manufacturers—must test glycerin prior to use to prevent DEG
contamination in finished products. The FDA has worked ex-
tensively with the USP to modify the glycerin monograph, and
these standards support the revised USP method.
Glycerin Standard Mix (3 components)
In P&T methanol, 1 mL/ampul
cat.# 31892 (ea.)
Diethylene glycol (111-46-6) 0.5 mg/mL
Ethylene glycol (107-21-1) 0.5
Propylene glycol (57-55-6) 20
Propylene Glycol Standard Mix (3 components)
Diethylene & Ethylene Glycol
0.8 mg/mL each in acetone:water (96:4), 1 mL/ampul
cat.# 31893 (ea.)
Diethylene glycol (111-46-6)
Ethylene glycol (107-21-1)
Sorbitol Standard Mix (2 components)
10 mg/mL in P&T methanol, 1 mL/ampul
cat.# 31894 (ea.)
2,2,2-Trichloroethanol (115-20-8)
Glycol Internal Standard Mix
100 mg total
cat.# 35100 (ea.)
No data pack available.
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 [cis 9]) 20
Methyl palmitate (C16:0) 10
Methyl stearate (C18:0) 20
EP 2.4.22 Composition of Fatty Acids by GC Mix 1
(6 components)
100 mg total
cat.# 35101 (ea.)
No data pack available.
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
EP 2.4.22 Composition of Fatty Acids by GC Mix 2
(5 components)
Pharmaceutical Compounds
in Drinking Water
200 µg/mL each in P&T methanol, 1 mL/ampul
cat.# 31116 (ea.)
Acetaminophen (103-90-2)
Caffeine (58-08-2)
Carbamazepine (298-46-4)
Ciprofloxacin HCL (86393-32-0)
Erythromycin USP (114-07-8)
Fluoxetine HCl (56296-78-7)
Sulfamethoxazole (723-46-6)
Trimethoprim (738-70-5)
Pharmaceuticals Mix #1 (8 components)
200 µg/mL each in acetonitrile, 1 mL/ampul
cat.# 31117 (ea.)
Bisphenol A (80-05-7)
Diclofenac sodium salt (15307-79-6)
17-beta-Estradiol (50-28-2)
Estrone (53-16-7)
17-alpha-Ethynylestradiol (57-63-6)
4-para-Nonylphenol (84852-15-3)
4-tert-Octylphenol (140-66-9)
Primidone (125-33-7)
Progestrone (57-83-0)
Testosterone (58-22-0)
Steroids and Mixed Pharmaceuticals Mix
(10 components)
200 µg/mL each in P&T methanol, 1 mL/ampul
cat.# 31118 (ea.)
Gemfibrozil (25812-30-0)
Ibuprofen (15687-27-1)
Naproxen (22204-53-1)
Triclosan (3380-34-5)
Pharmaceuticals Mix #2 (4 components)
Plastic Container Testing
50 µg/mL each in isopropanol, 1 mL/ampul
cat.# 31628 (ea.)
BHT (128-37-0)
Erucamide slip (112-84-5)
Vitamin E (59-02-9)
Irgafos 168 (31570-04-4)
Irganox 3114 (27676-62-6)
Irganox 1010 (6683-19-8)
Irganox 1076 (2082-79-3)
ASTMMethod D6042-96
(Plastic Container Testing)
American Society for Testing and Materials (ASTM Interna-
tional) Method D6042-96—Test Method for Determination
of Phenolic Antioxidants and Erucamide Slip Additives in
Polypropylene Homopolymer Formulations Using Liquid Chro-
matography—is a “consensus” or “referee” method used among
plastic manufacturers and the pharmaceutical companies that
purchase plastic containers. Plastic container manufacturers use
this test to ensure the quality of their product for their phar-
maceutical 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, LC separation, and
UV detection. Restek offers a variety of reversed-phase LC col-
umns suitable for these separations. Restek also designed a ref-
erence standard to validate this method. This mixture contains
the common antioxidants and slips listed in ASTM D6042-96,
along with BHT.
ASTM D6042-96 Calibration Mix (7 components)