95636
Extractables and Leachables Screening Standard for LC
certified reference material, TraceCERT®, 21 components in acetonitrile, Manufactured by: Sigma-Aldrich Production GmbH, Switzerland
Recommended Products
grade
certified reference material
TraceCERT®
Quality Level
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
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
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
Legal Information
Analyte
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
Certificates of Analysis (COA)
Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.
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Articles
Ascentis® C18 column facilitates LC-UV/MS analysis of extractables from single-use systems, ensuring reliable identification and quantification.
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