Skip to Content
MilliporeSigma
All Photos(1)

Documents

95636

Supelco

Extractables and Leachables Screening Standard for LC

certified reference material, TraceCERT®, 21 components in acetonitrile, Manufactured by: Sigma-Aldrich Production GmbH, Switzerland

Sign Into View Organizational & Contract Pricing
All Photos(1)

About This Item

UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
TraceCERT®

Quality Level

300

quality

21 components in acetonitrile

shelf life

limited shelf life, expiry date on the label

manufacturer/tradename

Manufactured by: Sigma-Aldrich Production GmbH, Switzerland

concentration

50 mg/L each component (nominal concentration)

application(s)

pharmaceutical

format

multi-component solution

storage temp.

−20°C

Related Categories

General description

This certified reference material (CRM) is produced and certified in accordance with ISO/IEC 17025 and ISO 17034. This CRM is traceable to the SI through a primary reference material from an NMI, e.g. NIST, NRC or NMIJ.
Certified content incl. uncertainty and expiry date are given on the certificate.
Download your certificate at: http://www.sigma-aldrich.com.

Check out our complete range of extractables and leachables certified reference mixes

Application

The certified reference material (CRM) is intended to be used as a calibrant for Extractables and Leachables testing in various plastic compounds.

Certified Reference Mixtures in ExtractablesScreening of Polymeric Materials: For Container–Closure Systems and Single-UseEquipment (article in bioprocess international )

Extractables Study with LC-UV/MS - Efficient identification and quantification of unknownextractables of a single-use system using the certified reference material(CRM) mix for extractables and leachables article from AnalytixReporter issue 12


Features and Benefits

  • Produced and certified under ISO/IEC 17025 and ISO 17034 accreditation
  • Traceable to certified NIST SRMs
  • Accompanied with a comprehensive Certificate of Analysis (CoA) (up to four pages), following ISO Guide 31, with data on stability, density, homogeneity, the accuracy of concentration, uncertainty, and traceability
  • Gravimetrically prepared using high-quality qNMR-characterized starting materials and qualified precision balances to ensure minimal uncertainty
  • Rigorously tested through real-time stability studies to ensure accuracy and shelf life
  • Available in well-sealed amber glass ampules

Preparation Note

For the preparation of this CRM only materials of highest purity were used.

Legal Information

TraceCERT is a registered trademark of Merck KGaA, Darmstadt, Germany

Analyte

Description
    Pentaerythritol tetrakis(3,5-di-tert-butyl-4-hydroxyhydrocinnamate)
    Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
    2-(2-Hydroxy-5-methylphenyl)benzotriazole
    ε-Caprolactam
    Dibenzylamine
    Benzoic acid
    2-Mercaptobenzothiazole
    Bisphenol A
    2-Ethylhexanoic acid
    Bis(4-chlorophenyl) sulfone
    3,5-Di-tert-butyl-4-hydroxybenzyl alcohol
    2,6-Di-tert-butyl-4-methylphenol
    1,3-Di-tert-butylbenzene
    Oleamide
    Bis(2-ethylhexyl) phthalate
    Stearic acid
    cis-13-Docosenoamide
    Tris(3,5-di-tert-butyl-4-hydroxybenzyl) isocyanurate
    Tris(2,4-di-tert-butylphenyl)phosphate
    2,4-Di-tert-butylphenol
    Palmitic acid
    See All (21)

pictograms

FlameExclamation mark
GHS02,GHS07

signalword

Danger

Hazard Classifications

Acute Tox. 4 Dermal - Acute Tox. 4 Inhalation - Acute Tox. 4 Oral - Eye Irrit. 2 - Flam. Liq. 2

wgk_germany

WGK 2

Choose from one of the most recent versions:

Certificates of Analysis (COA)

Lot/Batch Number
BCCF4251
BCCF8310
BCCF8311
BCCB7650

Don't see the Right Version?

If you require a particular version, you can look up a specific certificate by the Lot or Batch number.

Search for a COA

Already Own This Product?

Find documentation for the products that you have recently purchased in the Document Library.

Visit the Document Library

Customers Also Viewed

Slide 1 of 1

1 of 1

Sigma-Aldrich

Sigma-Aldrich

SRE0027

Heparin sodium porcine mucosa

Articles

Extractables Study with LC-UV/MS

Reliable identification and quantification of unknown extractables of a single-use system (SUS) with a 21 component CRM mix for liquid chromatography (LC-UV/MS) methods using Ascentis® C18 column.

Our team of scientists has experience in all areas of research including Life Science, Material Science, Chemical Synthesis, Chromatography, Analytical and many others.

Contact Technical Service