Reference Materials for Extractables and Leachables Testing –
New Certified Reference Materials Solution Mixes

Matthias Nold, Product Manager Reference Materials

Extractables and leachables testingExtractables and leachables (E&L) are chemical compounds with the potential to migrate into pharmaceutical or clinical products from packaging materials, tubing, or medical devices. This can lead to patient exposure to these compounds.

Extensive E&L studies to identify compounds that might leach into the product are obligatory for pharmaceutical products and medical devices.

Since it is never entirely predictable which chemicals could migrate, it is crucial that no potential extractables and leachables are overlooked in the analysis. Depending on the nature of the packaging material, the product, and the applied conditions, new unexpected or unknown compounds may be found. There is, therefore, no finite list of analytes for which products should be tested. However, there are certain monomers or additives that are more commonly detected in studies examining extractables and leachables.

In Issue 6 of Analytix Reporter we presented a new series of neat reference materials for some of the most frequently found extractables and leachables. To facilitate your identification and quantification of these extractables and leachables, we developed two certified calibration mixes for extractables and leachables. One mix is designed for LC (21 components) and another one for GC detection (14 components). These two products are Certified Reference Materials (CRM) produced under ISO/IEC 17025 and ISO 17034 double accreditation:

  • Certification of each individual component by qNMR (following ISO/IEC 17025 accreditation)
  • Mixes produced following the ISO 17034 workflow
  • Tested for homogeneity and long-term stability using GC-MS
  • Traceability to NIST SRMs
  • Supplied with a comprehensive certificate including the overall uncertainty

The components were chosen to reflect a broad spectrum of typical extractables and leachables compound classes, taking into account the toxicity and also how frequently they are typically found in E&L tests.

LC mix - 21 components

Catalog number: 95636
Product name: Extractables and leachables screening standard for LC
Type: Certified reference material, TraceCERT®
Concentrations: 50 µg/mL per component in acetonitrile
Package size: 1 mL

 

Compound CAS
Irganox 1010 (Ir 1010) 6683-19-8
Irganox 1076 (Ir1076) 2082-79-3
Dometrizol (Dome) / Tinuvin P/2-(2H-Benzotriazol-
2-yl)-p-cresol
2440-22-4
ε-Caprolactam (CAP) 105-60-2
Dibenzylamine (DBA) 103-49-1
Benzoic acid (BA) 65-85-0
2-Mercaptobenzothiazole (2-MBT) 149-30-4
Bisphenol A (BPA) 80-05-7
2-Ethylhexanoic acid (EHA) 149-57-5
Bis(4-chlorophenyl)sulfone (CPS) 80-07-9
2,6-Di-tert-butyl-4-
hydroxymethyl-phenol (DBOHP)
88-26-6
Butylhydroxytoluene (BHT) 128-37-0
1,3-Di-tert-butyl-benzene (DBB) 1014-60-4
Oleamide (Ole) 301-02-0
Bis(2-ethylhexyl) phthalate (DEHP) 117-81-7
Stearic acid (SA) 57-11-4
Erucamide (Eruca) 112-84-5
Irganox 3114 (Ir3114) 27676-62-6
Irgafos 168-oxide 95906-11-9
2,4-di-tert-Butylphenol 96-76-4
Palmitic acid 57-10-3

GC mix - 14 components

Catalog number: 01829
Product name: Extractables and leachables screening
standard for GC
Type: TraceCERT® certified reference material
Concentrations: 50 µg/mL per component in TBME
Package size: 1 mL

 

Compound CAS
Irganox 1076 (Ir1076) 2082-79-3
ε-Caprolactam (CAP) 105-60-2
2-Mercaptobenzothiazole (2-MBT) 149-30-4
Bisphenol A (BPA) 80-05-7
Butylhydroxytoluene (BHT) 128-37-0
1,3-Di-tert-butyl-benzene (DBB) 1014-60-4
Oleamide (Ole) 301-02-0
Bis(2-ethylhexyl) phthalate (DEHP) 117-81-7
Stearic acid (SA) 57-11-4
Erucamide (Eruca) 112-84-5
Irgafos 168-oxide 95906-11-9
2,4-di-tert-Butylphenol 96-76-4
2,6-di-tert-Butylphenol 128-39-2
Palmitic acid 57-10-3

Materials