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Documenti fondamentali

69729

Supelco

Elemental Impurities according to ICH Q3D oral, Standard 3

TraceCERT®, in nitric acid and hydrofluoric acid (5% nitric acid and <0.5% hydrofluoric acid ), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

Sinonimo/i:

ICH Q3D oral elemental impurities

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About This Item

Codice UNSPSC:
41116107
NACRES:
NA.24

Grado

certified reference material
TraceCERT®

Livello qualitativo

300

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

Ba, 140 mg/L
Cr, 1100 mg/L
Cu, 300 mg/L
Li, 55 mg/L
Mo, 300 mg/L
Sb, 120 mg/L
Sn, 600 mg/L

Concentrazione

in nitric acid and hydrofluoric acid (5% nitric acid and <0.5% hydrofluoric acid )

tecniche

ICP: suitable

Formato

multi-component solution

Descrizione generale

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 sulla preparazione

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

Altre note

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.

Note legali

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

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Descrizione
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19041

Elemental Impurities according to ICH Q3D oral, Standard 1, TraceCERT®, (in 12% nitric acid), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

73108

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

89922

Elemental Impurities according to ICH Q3D parenteral, Standard 2, TraceCERT®, (in 10% hydrochloric acid), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

07368

Elemental Impurities according to ICH Q3D parenteral, cutaneous and transcutaneous, Standard 3, TraceCERT®, in nitric acid and hydrofluoric acid (5% nitric acid and <0.5% hydrofluoric acid ), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

89118

Elemental Impurities according to ICH Q3D parenteral, Standard 1, (in 12% nitric acid), TraceCERT®, applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

Pittogrammi

CorrosionExclamation mark
GHS05,GHS07

Avvertenze

Danger

Indicazioni di pericolo

H290,H302 + H312,H314

Classi di pericolo

Acute Tox. 4 Dermal - Acute Tox. 4 Oral - Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B

Rischi supp

EUH071

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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Certificati d'analisi (COA)

Lot/Batch Number

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Articoli

Elemental Impurities - Certified Reference Materials for ICH Q3D, USP 232, USP 2232, and Ph.Eur. 5.20

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.

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.

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..

Contatta l'Assistenza Tecnica.