Merck, 95636-1ML, Extractables and Leachables Screening Standard for LC

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.

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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