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Key Documents

01829

Supelco

Extractables and Leachables Screening Standard for GC

certified reference material, TraceCERT®, 14 components in tert-Butyl methyl ether, Manufactured by: Sigma-Aldrich Production GmbH, Switzerland

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About This Item

UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
TraceCERT®

Quality Level

300

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

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

Extractables Study with GC/MS - Extractables Studies of Single-Use Equipment article from >AnalytixReporter issue 8

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
    Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
    ε-Caprolactam
    2-Mercaptobenzothiazole
    Bisphenol A
    3,5-Di-tert-butyl-4-hydroxytoluene
    1,3-Di-tert-butylbenzene
    Oleamide
    Bis(2-ethylhexyl) phthalate
    Stearic acid
    cis-13-Docosenoamide
    Tris(2,4-di-tert-butylphenyl)phosphate
    2,4-Di-tert-butylphenol
    2,6-Di-tert-butylphenol
    Palmitic acid
    See All (14)

Pictograms

FlameExclamation mark
GHS02,GHS07

Signal Word

Danger

Hazard Statements

H225,H315

Hazard Classifications

Flam. Liq. 2 - Skin Irrit. 2

Storage Class Code

3 - Flammable liquids

WGK

WGK 1

Flash Point(F)

-18.4 °F - closed cup

Flash Point(C)

-28 °C - closed cup

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Certificates of Analysis (COA)

Lot/Batch Number
BCCJ7283
BCCF9891
BCCF9892
BCCB7760

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Articles

Extractables Studies of Single-Use Equipment Immediate Identification and Quantification of Unknown Extractables by GC/MS with a Certified Reference Material Mix for Extractables and Leachables

Identification and quantification of the most common extractables originating from single-use equipment by GC/MS and an Extractables and Leachables Screening Standard.

Extractables Study with LC-UV/MS

Ascentis® C18 column facilitates LC-UV/MS analysis of extractables from single-use systems, ensuring reliable identification and quantification.

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

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