Passa al contenuto
Merck
Tutte le immagini(1)

Documenti fondamentali

89118

Supelco

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

Sinonimo/i:

ICH Q3D Elemental Impurity Analysis Standard

Autenticatiper visualizzare i prezzi riservati alla tua organizzazione & contrattuali
Tutte le immagini(1)

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

Ag, 10 mg/L
As, 15 mg/L
Cd, 2 mg/L
Co, 5 mg/L
Hg, 3 mg/L
Ni, 20 mg/L
Pb, 5 mg/L
Se, 80 mg/L
Tl, 8 mg/L
V, 10 mg/L

Concentrazione

(in 12% nitric acid)

tecniche

ICP: suitable

Formato

multi-component solution

Categorie correlate

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

Prodotti correlati

N° Catalogo
Descrizione
Determinazione del prezzo

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

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

Pittogrammi

Corrosion
GHS05

Avvertenze

Danger

Indicazioni di pericolo

H290,H314

Classi di pericolo

Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B

Rischi supp

EUH071

Classe di pericolosità dell'acqua (WGK)

WGK 2

Scegli una delle versioni più recenti:

Certificati d'analisi (COA)

Lot/Batch Number

It looks like we've run into a problem, but you can still download Certificates of Analysis from our Documenti section.

Se ti serve aiuto, non esitare a contattarci Servizio Clienti

Possiedi già questo prodotto?

I documenti relativi ai prodotti acquistati recentemente sono disponibili nell’Archivio dei documenti.

Visita l’Archivio dei documenti

I clienti hanno visto anche

Slide 1 of 4

1 of 4

Periodic table mix 2 for ICP TraceCERT&#174;, 17 elements, 10&#160;mg/L

Supelco

41135

Periodic table mix 2 for ICP

Transition metal mix 3 for ICP TraceCERT&#174;, 7 elements, 100&#160;mg/L in hydrochloric acid

Supelco

93468

Transition metal mix 3 for ICP

Rare earth element mix for ICP TraceCERT&#174;, 16 elements, 50&#160;mg/L in nitric acid

Supelco

67349

Rare earth element mix for ICP

Multielement Standard Solution 6 for ICP TraceCERT&#174;, 23 elements, 100 mg/L each in nitric acid and hydrofluoric acid

Supelco

43843

Multielement Standard Solution 6 for ICP

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.