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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

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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

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 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.

Applicazioni


  • Application of ICH Guidelines for the Assessment and Control of Elemental Impurities in Parecoxib Sodium by Graphite-Digestion and ICP-MS: This research demonstrates the application of ICH Q3D guidelines for evaluating elemental impurities in parenteral formulations, specifically using graphite-digestion and ICP-MS techniques on Parecoxib Sodium. This approach ensures compliance with pharmaceutical safety standards, emphasizing its critical role in maintaining drug quality and patient safety (Hao et al., 2022).

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

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

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Certificati d'analisi (COA)

Lot/Batch Number
BCCL9047
BCCL4692
BCCH4962
BCCG4736
BCCF6841

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Articoli

Elemental Impurities - Certified Ref. Materials

Control elemental impurities in drug products with analytical methods and materials to ensure patient safety.

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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