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73108

Supelco

Elemental Impurities according to ICH Q3D oral, Standard 2

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

Sinonimo/i:

ICH Q3D Elemental Impurity Analysis

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About This Item

Codice UNSPSC:
41116107
NACRES:
NA.24

Grado

certified reference material
TraceCERT®

Livello qualitativo

agenzia

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

Nome Commerciale

TraceCERT®

Durata

limited shelf life, expiry date on the label

Composizione

Au, 100 mg/L
Ir, 100 mg/L
Os, 100 mg/L
Pd, 100 mg/L
Pt, 100 mg/L
Rh, 100 mg/L
Ru, 100 mg/L

Concentrazione

(in 10% hydrochloric acid)

tecniche

ICP: suitable

Formato

multi-component solution

Descrizione generale

This certified reference material (CRM) is produced and certified in accordance with ISO/IEC 17025 and ISO 17034. This CRM is traceable to SI unit kg and measured against primary material from an NMI, e.g. NIST.
Certified content incl. uncertainty and expiry date are given on the certificate.
Download your certificate at: http://www.sigma-aldrich.com.

Nota sulla preparazione

For the preparation of this CRM only materials of highest purity were used.

Note legali

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

Pittogrammi

CorrosionExclamation mark

Avvertenze

Warning

Indicazioni di pericolo

Classi di pericolo

Met. Corr. 1 - Skin Irrit. 2 - STOT SE 3

Organi bersaglio

Respiratory system

Codice della classe di stoccaggio

8B - Non-combustible corrosive hazardous materials

Classe di pericolosità dell'acqua (WGK)

WGK 1

Punto d’infiammabilità (°F)

Not applicable

Punto d’infiammabilità (°C)

Not applicable


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Articoli

Elemental impurities in drug products pose a risk to patient health due to toxicological effects, and their levels should be controlled within acceptable limits. Find analytical methods and materials for impurity assessment.

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.

Il team dei nostri ricercatori vanta grande esperienza in tutte le aree della ricerca quali Life Science, scienza dei materiali, sintesi chimica, cromatografia, discipline analitiche, ecc..

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