Pular para o conteúdo
Merck
Todas as fotos(1)

Documentos Principais

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

Sinônimo(s):

ICH Q3D Elemental Impurity Analysis

Faça loginpara ver os preços organizacionais e de contrato
Todas as fotos(1)

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, 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

concentração

(in 10% hydrochloric acid)

técnica(s)

ICP: suitable

Formato

multi-component solution

Descrição geral

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 de preparo

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

Informações legais

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

Não está encontrando o produto certo?  

Experimente o nosso Ferramenta de seleção de produtos.

produto relacionado

Nº do produto
Descrição
Preços

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

69729

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

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

Pictogramas

CorrosionExclamation mark
GHS05,GHS07

Palavra indicadora

Warning

Frases de perigo

H290,H315,H335

Classificações de perigo

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

Órgãos-alvo

Respiratory system

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

Escolha uma das versões mais recentes:

Certificados de análise (COA)

Lot/Batch Number
BCCK6238
BCCJ7676
BCCH3725
BCCG5467
BCCF9648

Não está vendo a versão correta?

Se precisar de uma versão específica, você pode procurar um certificado específico pelo número do lote ou da remessa.

Pesquise por COA

Já possui este produto?

Encontre a documentação dos produtos que você adquiriu recentemente na biblioteca de documentos.

Visite a Biblioteca de Documentos

Os clientes também visualizaram

Slide 1 of 4

1 of 4

Metalloid and non-metal mix for ICP TraceCERT&#174;, 10 elements

Supelco

55263

Metalloid and non-metal mix for ICP

Multielement standard solution 3 for ICP TraceCERT&#174;, in 5% nitric acid

Supelco

49596

Multielement standard solution 3 for ICP

Multielement standard solution 4 for ICP TraceCERT&#174;, in 10% nitric acid

Supelco

51844

Multielement standard solution 4 for ICP

ICP multi-element standard solution I (19 elements in dilute nitric acid) Certipur&#174;

Supelco

1.15474

ICP multi-element standard solution I

Artigos

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.

Nossa equipe de cientistas tem experiência em todas as áreas de pesquisa, incluindo Life Sciences, ciência de materiais, síntese química, cromatografia, química analítica e muitas outras.

Entre em contato com a assistência técnica