Extractables and Leachables

Extractables and Leachables (E&L) are chemical compounds with the potential to migrate into pharmaceutical or clinical products from packaging materials, tubings or medical devices and thus can be exposed to patients.
Manufacturers of pharmaceutical products and medical devices are obliged to perform extensive E&L studies to identify compounds that might leach into the product and, if necessary assess the toxicity of these chemicals.
Since it is never entirely predictable what migrants can occur, it is crucial that no analytes are overlooked. Depending on the nature of the packaging material, the product and the applied conditions, new unexpected or unknown compounds can be found. Therefore, there is no finite list of analytes to be tested for. However there are certain monomers or additives that can very often be detected in extractables and leachables studies.

To facilitate identification and quantification of extractables and leachables, we offer a comprehensive portfolio of reference materials. A list of more than 200 certified reference materials and analytical standards for commonly found extractables and leachables can be found below

Please also check out our Emprove® program and BioReliance® Validation Services for Extractables & Leachables

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01829   Extractables and Leachables Screening Standard for GC certified reference material, TraceCERT®, 14 components in tert-Butyl methyl ether
95636   Extractables and Leachables Screening Standard for LC certified reference material, TraceCERT®, 21 components in acetonitrile
05426 Acenaphthene certified reference material, TraceCERT®
92549 Acenaphthylene certified reference material, TraceCERT®
89898 Acetamide analytical standard
90872 Acetone analytical standard
63634 Acetophenone certified reference material, TraceCERT®
01973 4-Aminobenzoic acid analytical standard
68985 4-tert-Amylphenol PESTANAL®, analytical standard
07671 Anthracene certified reference material, TraceCERT®
39383 Arachidic acid analytical standard
30958 Benzo[b]fluoranthene certified reference material, TraceCERT®
03323 Benzo[k]fluoranthene certified reference material, TraceCERT®
06185 Benzoic acid Standard for quantitative NMR, TraceCERT®
55488 Benzo[ghi]perylene certified reference material, TraceCERT®
51968 Benzo[a]pyrene certified reference material, TraceCERT®
36962 Benzo[e]pyrene solution 100 μg/mL in cyclohexane, analytical standard
PHR1028 1,4-Benzoquinone Pharmaceutical Secondary Standard; Certified Reference Material
61427 Benzothiazole analytical standard
PHR1019 Benzyl alcohol Pharmaceutical Secondary Standard; Certified Reference Material
39971 Benzyl alcohol certified reference material, TraceCERT®
42438 Benzyl butyl phthalate certified reference material, TraceCERT®
96153 Bis(4-chlorophenyl) sulfone reference material
67261 Bis(2-ethylhexyl) phthalate certified reference material, TraceCERT®
49234 Bis(2-ethylhexyl) terephthalate analytical standard
96142 Bis[4-(glycidyloxy)phenyl]methane reference material
1075688 Bisoctrizole Related Compound A United States Pharmacopeia (USP) Reference Standard
42088 Bisphenol A certified reference material, TraceCERT®
15137 Bisphenol A bis(2,3-dihydroxypropyl) ether analytical standard
15138 Bisphenol A diglycidyl ether analytical standard
50621 tert-Butanol analytical standard
02469 2-Butanone analytical standard
49886 Butylated hydroxyanisole certified reference material, TraceCERT®
07293 tert-Butylhydroquinone analytical standard
08603 tert-Butyl methyl ether analytical standard
94194 Butyraldehyde analytical standard, contains ~0.1% 2,6-di-tert-butyl-4-methylphenol and ~1% water as stabilizer
77403 ε-Caprolactam analytical standard
01483 ε-Caprolactam reference material
08650 Chlorobenzene analytical standard
35826 4-Chlorophenol PESTANAL®, analytical standard
94035 Chrysene certified reference material, TraceCERT®
36922 o-Cresol analytical standard
65996 m-Cresol analytical standard
42429 p-Cresol analytical standard
44113 Cyclohexanol analytical standard
02482 Cyclohexanone analytical standard
442543 Decafluorotriphenylphosphine analytical standard
48082   Decafluorotriphenylphosphine solution certified reference material, 2000 μg/mL in dichloromethane
43217 Decamethylcyclopentasiloxane analytical standard
21409 Decanoic acid analytical standard
18139 4,4′-Diaminodiphenylmethane certified reference material, TraceCERT®
91861 Dibenz[a,h]anthracene certified reference material, TraceCERT®
95728 Dibenzylamine reference material New
96659 1,3-Di-tert-butylbenzene reference material
49751 2,4-Di-tert-butyl-6-(5-chloro-2H-benzotriazol-2-yl)phenol certified reference material, TraceCERT®
96857 3,5-Di-tert-butyl-4-hydroxybenzyl alcohol reference material
75918 2,6-Di-tert-butyl-4-methylphenol certified reference material, TraceCERT®
00437 2,4-Di-tert-butylphenol reference material
96852 2,6-Di-tert-butylphenol reference material
18281 Dibutyl phthalate certified reference material, TraceCERT®
36749 2,4-Dichlorobenzoic acid PESTANAL®, analytical standard
16957 Diethanolamine analytical standard
42697 Diethyl adipate analytical standard
03128 Diethylene glycol analytical standard
91238 Diethyl ether analytical standard
47995-U   Di(2-ethylhexyl)adipate solution certified reference material, 2000 μg/mL in methanol
43540 Diisobutyl phthalate certified reference material, TraceCERT®
36715 2,6-Dimethylphenol PESTANAL®, analytical standard
40069   Dimethyl phthalate solution certified reference material, 5000 μg/mL in methanol
76048 Dimethyl sulfide analytical standard
07038 Dimethyl terephthalate Standard for quantitative NMR, TraceCERT®
88173 Di-n-octyl phthalate certified reference material, TraceCERT®
92841 Dioxybenzone analytical standard
45456 Diphenylamine PESTANAL®, analytical standard
D2900000 Disodium edetate European Pharmacopoeia (EP) Reference Standard
33154 Dithizone puriss. p.a., Reag. Ph. Eur., ≥98% (chelatometric), for metal titration
01374 cis-13-Docosenoamide reference material New
43216 Dodecamethylcyclohexasiloxane analytical standard
92064 Dodecane certified reference material, TraceCERT®
44146 1-Dodecene analytical standard
1228009 Drometrizole United States Pharmacopeia (USP) Reference Standard
45089 Elaidic acid analytical standard
43956   Epoxidized soya bean oil analytical standard
90082 Erucamide analytical standard
73132 meso-Erythritol analytical standard
58958 Ethyl acetate analytical standard
PHR1481 Ethyl Acetate Pharmaceutical Secondary Standard; Certified Reference Material
03079 Ethylbenzene analytical standard
41008 Ethylenediamine analytical standard
PHR1068 Ethylenediaminetetraacetic acid disodium salt dihydrate Pharmaceutical Secondary Standard; Certified Reference Material
53071 Ethylene glycol butyl ether analytical standard
02529 2-Ethylhexanoic acid analytical standard
PHR1914 2-Ethylhexanoic acid Pharmaceutical Secondary Standard; Certified Reference Material
08607 2-Ethyl-1-hexanol analytical standard
67107 Ethyl palmitate analytical standard
11474 Fluoranthene certified reference material, TraceCERT®
56849 Fluorene certified reference material, TraceCERT®
51559 Heptacosane analytical standard
43858 Heptanoic acid analytical standard
52183 Hexacosane analytical standard
52276 1-Hexadecene analytical standard
38677 Hexamethylcyclotrisiloxane analytical standard
18109 Hexanal analytical standard
52750 Hexane analytical standard
52930 1-Hexene analytical standard
50797 Hexylene glycol analytical standard
18245 2′-Hydroxyacetophenone analytical standard
01479 2-Hydroxy-4-methoxybenzophenone certified reference material, TraceCERT®
78891 4-Hydroxy-4-methyl-2-pentanone analytical standard
96697 2-(2-Hydroxy-5-methylphenyl)benzotriazole reference material
94377 Indeno[1,2,3-cd]pyrene certified reference material, TraceCERT®
59240 Isoprene analytical standard
PHR1580 Lauric Acid Pharmaceutical Secondary Standard; Certified Reference Material
PHR1007 Mannitol Pharmaceutical Secondary Standard; Certified Reference Material
50296 Melting point standard 47-49°C analytical standard
96051 2-Mercaptobenzothiazole reference material
82762 Methanol analytical standard
73096 2,2′-Methylenebis(6-tert-butyl-4-ethylphenol) certified reference material, TraceCERT®
50374 Methyl palmitate certified reference material, TraceCERT®
68450 2-Methyl-1-pentene analytical standard
49722 4-Methyl-3-penten-2-one analytical standard
75533 Methyl stearate certified reference material, TraceCERT®
90179 Morpholine analytical standard
70079 Myristic acid analytical standard
91489 Naphthalene certified reference material, TraceCERT®
74158 Nonadecane analytical standard
04029 4-Nonylphenol certified reference material, TraceCERT®
74691 Octadecane analytical standard
74738 1-Octadecene analytical standard
00318 Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate reference material
43883 Octamethylcyclotetrasiloxane analytical standard
07754 Octanoic acid certified reference material, TraceCERT®
02479 2-Octanone analytical standard
94551 4-tert-Octylphenol certified reference material, TraceCERT®
08393 Oleamide analytical standard
96709 Oleamide reference material
PHR1586 Oleic Acid Pharmaceutical Secondary Standard; Certified Reference Material
PHR1074 Oxybenzone Pharmaceutical Secondary Standard; Certified Reference Material
76119 Palmitic acid analytical standard
PHR1120 Palmitic acid Pharmaceutical Secondary Standard; Certified Reference Material
43051 Palmitic acid certified reference material, TraceCERT®
76509 Pentadecane analytical standard
96656 Pentaerythritol tetrakis(3,5-di-tert-butyl-4-hydroxyhydrocinnamate) reference material
73338 Phenanthrene certified reference material, TraceCERT®
442753 Phenanthrene-d10 analytical standard
48094   Phenanthrene-d10 solution certified reference material, 2000 μg/mL in methanol
PHR1047 Phenol Pharmaceutical Secondary Standard; Certified Reference Material
35952 Phenol PESTANAL®, analytical standard
56753 2-Phenoxyethanol analytical standard
45529 2-Phenylphenol PESTANAL®, analytical standard
55906 Phthalide analytical standard
36734 Phthalimide PESTANAL®, analytical standard
P2155001 Plastic additive 01 European Pharmacopoeia (EP) Reference Standard
1544927 Plastic additive 1 United States Pharmacopeia (USP) Reference Standard
1544938 Plastic additive 2 United States Pharmacopeia (USP) Reference Standard
P2155003 Plastic additive 03 European Pharmacopoeia (EP) Reference Standard
1544949 Plastic additive 3 United States Pharmacopeia (USP) Reference Standard
1544950 Plastic additive 4 United States Pharmacopeia (USP) Reference Standard
P2155005   Plastic additive 05 European Pharmacopoeia (EP) Reference Standard
1544964 Plastic additive 5 United States Pharmacopeia (USP) Reference Standard
1544971 Plastic additive 6 United States Pharmacopeia (USP) Reference Standard
P2155008 Plastic additive 08 European Pharmacopoeia (EP) Reference Standard
1544993 Plastic additive 8 United States Pharmacopeia (USP) Reference Standard
P2155009 Plastic additive 09 European Pharmacopoeia (EP) Reference Standard
1545001 Plastic additive 9 United States Pharmacopeia (USP) Reference Standard
P2155010 Plastic additive 10 European Pharmacopoeia (EP) Reference Standard
1545012 Plastic additive 10 United States Pharmacopeia (USP) Reference Standard
P2155011 Plastic additive 11 European Pharmacopoeia (EP) Reference Standard
1545023 Plastic additive 11 United States Pharmacopeia (USP) Reference Standard
P2155012 Plastic additive 12 European Pharmacopoeia (EP) Reference Standard
1545034 Plastic additive 12 United States Pharmacopeia (USP) Reference Standard
P2155013 Plastic additive 13 European Pharmacopoeia (EP) Reference Standard
1545045 Plastic additive 13 United States Pharmacopeia (USP) Reference Standard
P2155014 Plastic additive 14 European Pharmacopoeia (EP) Reference Standard
1545056 Plastic additive 14 United States Pharmacopeia (USP) Reference Standard
P2155015 Plastic additive 15 European Pharmacopoeia (EP) Reference Standard
1545067   Plastic additive 15 United States Pharmacopeia (USP) Reference Standard
P2155016 Plastic additive 16 European Pharmacopoeia (EP) Reference Standard
1545078   Plastic additive 16 United States Pharmacopeia (USP) Reference Standard
P2155017 Plastic additive 17 European Pharmacopoeia (EP) Reference Standard
1545089   Plastic Additive 17 United States Pharmacopeia (USP) Reference Standard
O0140000 Plastic additive 20 European Pharmacopoeia (EP) Reference Standard
E1260000   Plastic additive 21 European Pharmacopoeia (EP) Reference Standard
P2155022 Plastic additive 22 European Pharmacopoeia (EP) Reference Standard
P2155023   Plastic additive 23 European Pharmacopoeia (EP) Reference Standard
Y0002025 Plastic additive 25 European Pharmacopoeia (EP) Reference Standard
Y0002023 Plastic additive 26 European Pharmacopoeia (EP) Reference Standard
Y0002024 Plastic additive 27 European Pharmacopoeia (EP) Reference Standard
181846 Poly(dimethylsiloxane) analytical standard, average Mw 95,000 (Typical), average Mn 50,000 (Typical)
81153 Poly(dimethylsiloxane) analytical standard, for GPC, 311
PHR1518 Polydimethylsiloxane Pharmaceutical Secondary Standard; Certified Reference Material
02393 Polyethylene glycol/Polyethylene oxide ReadyCal Set Mp ~250 -1′000 000 analytical standard
91237 2-Propanol analytical standard
56671 (±)-Propylene oxide analytical standard
18868 Pyrene certified reference material, TraceCERT®
53363 Resorcinol certified reference material, TraceCERT®
47841 D-Sorbitol analytical standard
85679 Stearic acid analytical standard
76137 Stearic acid certified reference material, TraceCERT®
PHR1114 Stearic Acid Pharmaceutical Secondary Standard; Certified Reference Material
45993 Styrene analytical standard
36576 Sulfur PESTANAL®, analytical standard
33493 2,6-TDI analytical standard
40818 Terephthalic acid analytical standard
442734 p-Terphenyl-d14 analytical standard
48418 p-Terphenyl-d14 solution certified reference material, 2000 μg/mL in dichloromethane
46259 1,1,2,2-Tetrachloroethane analytical standard
87187 1-Tetradecene analytical standard
43966 Thiram certified reference material, TraceCERT®
CRM48593   Toluene-d8 solution certified reference material, TraceCERT®, 2000 μg/mL in methanol
74103 Triacetin analytical standard
34108 Tributyl phosphate analytical standard
73487 Triethylamine analytical standard
14849 Triethyl citrate analytical standard
05498 Triphenyl phosphate TraceCERT®, 31P-qNMR Standard
08902 Triphenylphosphine oxide analytical standard
96737 Tris(3,5-di-tert-butyl-4-hydroxybenzyl) isocyanurate reference material
96839 Tris(2,4-di-tert-butylphenyl)phosphate reference material
42272 Valeraldehyde analytical standard