New Reference Materials for Extractables and Leachables Testing

Matthias Nold, Product Manager Reference Materials

Pharmaceutical or clinical products from packaging materialsExtractables and Leachables (E&L) are chemical compounds with the potential to migrate into pharmaceutical or clinical products from packaging materials, tubing, or medical devices, resulting in patient exposure.

Manufacturers of pharmaceutical products and medical devices are obligated 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 which migrants may 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 are very often 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 100 certified reference materials and analytical standards for commonly found extractables and leachables can be found at SigmaAldrich.com/extractablesandleachables.

Recently we added a series of sixteen new reference materials to this range, which are listed below. These new products are provided with a NIST SRM traceable value determined by quantitative NMR (qNMR) in accordance with ISO/IEC 17025. The values are given with an uncertainty which takes into account the stability and homogeneity of the material. We are also developing certified reference materials (CRM) mixes for LC and GC which cover a broad range of compound classes that are most commonly found in extractables and leachables studies. Please regularly check our website for the most recent product additions.

Materials

Description Synonyms/Abbreviations         CAS Cat. No.
Pentaerythritol tetrakis(3,5-di-tert-butyl-4-hydroxyhydrocinnamate) Irganox 1010 (Ir 1010) 6683-19-8 96656
Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate Irganox 1076 (Ir1076) 2082-79-3 00318
2-(2-Hydroxy-5-methylphenyl)benzotriazol Dometrizol (Dome)/Tinuvin P 2440-22-4 96697
ε-Caprolactam CAP 105-60-2 01483
Dibenzylamine DBA 103-49-1 95728
2-Mercaptobenzothiazole 2-MBT 149-30-4 96051
Bis[4-(glycidyloxy)phenyl]methane, mixture of isomers Bisphenol F diglycidylether (BPFE) 2095-03-6 96142
Bis(4-chlorophenyl) sulfone CPS 80-07-9 96153
3,5-Di-tert-butyl-4-hydroxybenzyl alcohol 2,6-Di-tert-butyl-4-hydroxymethyl-phenol (DBOHP) 88-26-6 96857
1,3-Di-tert-butylbenzene DBB 1014-60-4 96659
Oleamide Ole 301-02-0 96709
cis-13-Docosenoamide Erucamide (Eruca) 112-84-5 01374
Tris(3,5-di-tert-butyl-4-hydroxybenzyl) isocyanurate Irganox 3114 (Ir3114) 27676-62-6 96737
Tris(2,4-di-tert-butylphenyl)phosphate Irgafos 168-oxide 95906-11-9 96839
2,4-Di-tert-butylphenol   96-76-4 00437
2,6-Di-tert-butylphenol   128-39-2 96852