Extractables and Leachables Screening Standard for LC

SKU:
95636-1ML
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    • Description

    Extractables and Leachables Screening Standard for LC

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

    About This Item

    UNSPSC Code:
    41116107
    NACRES:
    NA.24

    Properties

    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

    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 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

    Safety Information

    signalword

    Danger

    hcodes

    H225,H302 + H312 + H332,H319

    pcodes

    P210 - P280 - P301 + P312 - P303 + P361 + P353 - P304 + P340 + P312 - P305 + P351 + P338

    Hazard Classifications

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

    wgk_germany

    WGK 2