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Documentos Principais

93696

Supelco

Elemental Impurities according to 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

Código UNSPSC:
41116107
NACRES:
NA.24

grau

certified reference material
TraceCERT®

Nível de qualidade

300

Agency

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

linha de produto

TraceCERT®

prazo de validade

limited shelf life, expiry date on the label

composição

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

concentração

(in 10% hydrochloric acid)

técnica(s)

ICP: suitable

Formato

multi-component solution

Descrição geral

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.

Nota de análise

The concentrations are 10 fold according to ICH Q3D guideline.

Outras notas

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.

Informações legais

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

Pictogramas

Corrosion
GHS05

Palavra indicadora

Warning

Frases de perigo

H290

Declarações de precaução

P234 - P390

Classificações de perigo

Met. Corr. 1

Código de classe de armazenamento

8B - Non-combustible corrosive hazardous materials

Classe de risco de água (WGK)

WGK 1

Ponto de fulgor (°F)

Not applicable

Ponto de fulgor (°C)

Not applicable

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Certificados de análise (COA)

Lot/Batch Number

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Artigos

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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