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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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1 ML
€282.00
5 ML
€497.00

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1 ML
€282.00
5 ML
€497.00

About This Item

UNSPSC Code:
41116107
NACRES:
NA.24

€282.00

Please contact Customer Service for Availability
Request a Bulk Order

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

Related Categories

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

Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

EU REACH Annex XIV (Authorisation List)

CAS No.

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Certificates of Analysis (COA)

Lot/Batch Number

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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.

Questions

1–2 of 2 Questions  

  1. How can I determine the shelf life / expiration / retest date of this product?

    1 answer

    1. If this product has an expiration or retest date, it will be shown on the Certificate of Analysis (COA, CofA). If there is no retest or expiration date listed on the product's COA, we do not have suitable stability data to determine a shelf life. For these products, the only date on the COA will be the release date; a retest, expiration, or use-by-date will not be displayed.
      For all products, we recommend handling per defined conditions as printed in our product literature and website product descriptions. We recommend that products should be routinely inspected by customers to ensure they perform as expected.
      For products without retest or expiration dates, our standard warranty of 1 year from the date of shipment is applicable.
      For more information, please refer to the Product Dating Information document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/449/386/product-dating-information-mk.pdf

      Helpful?

  2. How is shipping temperature determined? And how is it related to the product storage temperature?

    1 answer

    1. Products may be shipped at a different temperature than the recommended long-term storage temperature. If the product quality is sensitive to short-term exposure to conditions other than the recommended long-term storage, it will be shipped on wet or dry-ice. If the product quality is NOT affected by short-term exposure to conditions other than the recommended long-term storage, it will be shipped at ambient temperature. As shipping routes are configured for minimum transit times, shipping at ambient temperature helps control shipping costs for our customers. For more information, please refer to the Storage and Transport Conditions document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/316/622/storage-transport-conditions-mk.pdf

      Helpful?

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