95636

Extractables and Leachables Screening Standard for LC

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

• 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

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)

Safety Information

• Pictograms: GHS02,GHS07
• Signal Word: Danger
• Hazard Statements: H225,H302 + H312 + H332,H319
• Precautionary Statements: 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
• Storage Class Code: 3 - Flammable liquids
• WGK: WGK 2
• Flash Point(F): 42.8 °F - closed cup
• Flash Point(C): 6.0 °C - closed cup