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95636

Extractables and Leachables Screening Standard for LC

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

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About This Item

NACRES:
NA.24
UNSPSC Code:
41116107
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Quality Segment

grade

certified reference material, TraceCERT®

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)

chemicals and industrial polymers
cosmetics
food and beverages
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
Discover our new Extractables and Leachables Silicone Mix with the most commonly found Silicone extractables

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
See All (21)

Pictograms

FlameExclamation mark
GHS02,GHS07

Signal Word

Danger

Hazard Classifications

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

Storage Class

3 - Flammable liquids

WGK

WGK 2

Flash Point (°F)

42.8 °F - closed cup

Flash Point (°C)

6.0 °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.

Deleterious substance

pdsc

Group 4: Flammable liquids + Type 1 petroleums + Hazardous rank II + Water insoluble liquid

fsl

Substances Subject to be Indicated Names

ishl_indicated

Substances Subject to be Notified Names

ishl_notified

95636-5ML-PW: + 95636-1ML-PW: + 95636-1ML:4548173360669 + 95636-VAR: + 95636-BULK: + 95636-5ML:4548173360676

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