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 80 certified reference materials and analytical standards for commonly found extractables and leachables can be found below

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39383 Arachidic acid analytical standard
06185 Benzoic acid Standard for quantitative NMR, TraceCERT®
PHR1028 1,4-Benzoquinone Pharmaceutical Secondary Standard; Certified Reference Material
39971 Benzyl alcohol certified reference material, TraceCERT®
PHR1019 Benzyl alcohol Pharmaceutical Secondary Standard; Certified Reference Material
96153 Bis(4-chlorophenyl) sulfone reference material New
67261 Bis(2-ethylhexyl) phthalate certified reference material, TraceCERT®
49234 Bis(2-ethylhexyl) terephthalate analytical standard
1075688 Bisoctrizole Related Compound A United States Pharmacopeia (USP) Reference Standard
86311 Bis(pentafluorophenyl)phenylphosphine analytical standard, for mass spectrometry
42088 Bisphenol A certified reference material, TraceCERT®
15137 Bisphenol A bis(2,3-dihydroxypropyl) ether analytical standard
442543 Decafluorotriphenylphosphine analytical standard
48082   Decafluorotriphenylphosphine solution certified reference material, 2000 μg/mL in dichloromethane
21409 Decanoic acid analytical standard
96659 1,3-Di-tert-butylbenzene reference material New
49751 2,4-Di-tert-butyl-6-(5-chloro-2H-benzotriazol-2-yl)phenol certified reference material, TraceCERT®
75918 2,6-Di-tert-butyl-4-methylphenol certified reference material, TraceCERT®
47995-U   Di(2-ethylhexyl)adipate solution certified reference material, 2000 μg/mL in methanol
40069   Dimethyl phthalate solution certified reference material, 5000 μg/mL in methanol
88173 Di-n-octyl phthalate certified reference material, TraceCERT®
D2900000 Disodium edetate European Pharmacopoeia (EP) Reference Standard
33154 Dithizone puriss. p.a., Reag. Ph. Eur., ≥98% (chelatometric), for metal titration
43216 Dodecamethylcyclohexasiloxane analytical standard
92064 Dodecane certified reference material, TraceCERT®
1228009 Drometrizole United States Pharmacopeia (USP) Reference Standard
06681   Epoxidized linseed oil analytical standard
43956   Epoxidized soya bean oil analytical standard
PHR1481 Ethyl Acetate
PHR1068 Ethylenediaminetetraacetic acid disodium salt dihydrate
02529 2-Ethylhexanoic acid analytical standard
PHR1914 2-Ethylhexanoic acid Pharmaceutical Secondary Standard; Certified Reference Material
67107 Ethyl palmitate analytical standard
51559 Heptacosane analytical standard
38677 Hexamethylcyclotrisiloxane analytical standard
18109 Hexanal analytical standard
01479 2-Hydroxy-4-methoxybenzophenone certified reference material, TraceCERT®
PHR1580 Lauric Acid Pharmaceutical Secondary Standard; Certified Reference Material
PHR1007 Mannitol Pharmaceutical Secondary Standard; Certified Reference Material
75533 Methyl stearate certified reference material, TraceCERT®
74158 Nonadecane analytical standard
43883 Octamethylcyclotetrasiloxane analytical standard
08393 Oleamide analytical standard
PHR1586 Oleic Acid Pharmaceutical Secondary Standard; Certified Reference Material
PHR1074 Oxybenzone Pharmaceutical Secondary Standard; Certified Reference Material
43051 Palmitic acid certified reference material, TraceCERT®
76119 Palmitic acid analytical standard
PHR1120 Palmitic acid Pharmaceutical Secondary Standard; Certified Reference Material
76509 Pentadecane analytical standard
442753 Phenanthrene-d10 analytical standard
48094   Phenanthrene-d10 solution certified reference material, 2000 μg/mL in methanol
PHR1047 Phenol
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
1545078   Plastic additive 16 United States Pharmacopeia (USP) Reference Standard
P2155016 Plastic additive 16 European Pharmacopoeia (EP) Reference Standard
P2155017 Plastic additive 17 European Pharmacopoeia (EP) Reference Standard
1545089   Plastic Additive 17 United States Pharmacopeia (USP) Reference Standard New
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
81153 Poly(dimethylsiloxane) analytical standard, for GPC, 311
PHR1518 Polydimethylsiloxane Pharmaceutical Secondary Standard; Certified Reference Material
47841 D-Sorbitol analytical standard
76137 Stearic acid certified reference material, TraceCERT®
85679 Stearic acid analytical standard
PHR1114 Stearic Acid Pharmaceutical Secondary Standard; Certified Reference Material
442734 p-Terphenyl-d14 analytical standard
48418 p-Terphenyl-d14 solution certified reference material, 2000 μg/mL in dichloromethane
442809 Toluene-d8 analytical standard
CRM48593   Toluene-d8 solution certified reference material, TraceCERT®, 2000 μg/mL in methanol
96737 Tris(3,5-di-tert-butyl-4-hydroxybenzyl) isocyanurate reference material New