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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

Sinónimos:

ICH Q3D oral elemental impurities

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About This Item

Código UNSPSC:
41116107
NACRES:
NA.24

grado

certified reference material
TraceCERT®

Nivel de calidad

300

Agency

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

Línea del producto

TraceCERT®

caducidad

limited shelf life, expiry date on the label

composición

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

concentración

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

técnicas

ICP: suitable

Formato

multi-component solution

Descripción general

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 preparación

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

Otras 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.

Información legal

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

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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

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Pictogramas

CorrosionExclamation mark
GHS05,GHS07

Palabra de señalización

Danger

Frases de peligro

H290,H302 + H312,H314

Clasificaciones de peligro

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

Riesgos supl.

EUH071

Código de clase de almacenamiento

8B - Non-combustible corrosive hazardous materials

Clase de riesgo para el agua (WGK)

WGK 1

Punto de inflamabilidad (°F)

Not applicable

Punto de inflamabilidad (°C)

Not applicable

Listados normativos

Los listados normativos se proporcionan para los productos químicos principalmente. Para los productos no químicos sólo se puede proporcionar información limitada. Si no hay ninguna entrada, significa que ninguno de los componentes está en la lista. Es obligación del usuario garantizar el uso seguro y legal del producto.

EU REACH Annex XVII (Restriction List)

CAS No.

Elija entre una de las versiones más recientes:

Certificados de análisis (COA)

Lot/Batch Number

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Artículos

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.

Nuestro equipo de científicos tiene experiencia en todas las áreas de investigación: Ciencias de la vida, Ciencia de los materiales, Síntesis química, Cromatografía, Analítica y muchas otras.

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