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Elementare Verunreinigungen nach ICH Q3D inhalation, Standard 2

TraceCERT®, (in 10% hydrochloric acid), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

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About This Item

UNSPSC-Code:
41116107
NACRES:
NA.24

Qualität

certified reference material
TraceCERT®

Qualitätsniveau

300

Agentur

according to ICH Q3D
according to Ph. Eur.
according to USP

Produktlinie

TraceCERT®

Haltbarkeit

limited shelf life, expiry date on the label

Zusammensetzung

Au, 10 mg/L
Ir, 10 mg/L
Os, 10 mg/L
Pd, 10 mg/L
Pt, 10 mg/L
Rh, 10 mg/L
Ru, 10 mg/L

Konzentration

(in 10% hydrochloric acid)

Methode(n)

ICP: suitable

Format

multi-component solution

Allgemeine Beschreibung

This certified reference material (CRM) is produced in accordance with ISO 17034 and characterized in accordance with ISO/IEC 17025. This CRM is traceable to SI unit kg and measured against primary material from a National Metrology Institute (NMI), e.g. NIST.

Please visit ISO certificates and Site Quality Self-Assessments to access the current certificates of accreditation.

Download your certificate at https://www.sigma-aldrich.com to view certified values, including uncertainty, date of expiry, and detailed information about trace impurities.

Hinweis zur Analyse

The concentrations are 10 fold according to ICH Q3D guideline.

Sonstige Hinweise

We provide a diverse range of certified reference materials, including various elemental impurity mixes and single elements, with concentration limits that comply with ICH Q3D guidelines. For more information please visit our Inorganic Elemental Impurity Mix Standards.

In our effort to be more sustainable, we′re going digital with COAs-download them directly from our website.

Rechtliche Hinweise

TraceCERT is a registered trademark of Merck KGaA, Darmstadt, Germany

Piktogramme

Corrosion
GHS05

Signalwort

Warning

H-Sätze

H290

P-Sätze

P234 - P390

Gefahreneinstufungen

Met. Corr. 1

Lagerklassenschlüssel

8B - Non-combustible corrosive hazardous materials

WGK

WGK 1

Flammpunkt (°F)

Not applicable

Flammpunkt (°C)

Not applicable

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Analysenzertifikate (COA)

Lot/Batch Number

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Artikel

Inorganic elemental impurity mixes according to ICH Q3D guidelines

In 2009, the International Conference on Harmonization (ICH) proposed the development of a new harmonized guideline to provide a global policy for limiting metal impurities in drug products and ingredients. This approach provides clear regulatory guidance on specification limits for elemental impurities worldwide and logically should have an impact on the work of the national regulatory bodies in having transparent and comparable results.

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