Extractables and Leachables Screening Standard for LC

Description

• 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 accreditationTraceable to certified NIST SRMsAccompanied 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 traceabilityGravimetrically prepared using high-quality qNMR-characterized starting materials and qualified precision balances to ensure minimal uncertaintyRigorously tested through real-time stability studies to ensure accuracy and shelf lifeAvailable 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