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Key Documents

19041

Supelco

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

Synonyme(s) :

TraceCERT Elemental Impurities according to ICH Q3D oral

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About This Item

Code UNSPSC :
41116107
Nomenclature NACRES :
NA.24

Qualité

certified reference material
TraceCERT®

Niveau de qualité

300

Agence

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

Gamme de produits

TraceCERT®

Durée de conservation

limited shelf life, expiry date on the label

Composition

Ag, 150 mg/L
As, 15 mg/L
Cd, 5 mg/L
Co, 50 mg/L
Hg, 30 mg/L
Ni, 200 mg/L
Pb, 5 mg/L
Se, 150 mg/L
Tl, 8 mg/L
V, 100 mg/L

Concentration

(in 12% nitric acid)

Technique(s)

ICP: suitable

Format

multi-component solution

Catégories apparentées

Description générale

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.

Application


  • Compatibility of oral magnesium oxide with ICH-Q3D: A study assessing the compatibility of oral magnesium oxide preparations with ICH-Q3D guidelines for elemental impurities ensures compliance with global standards, enhancing drug safety and efficacy (Satoh et al., 2021).

Notes préparatoires

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

Informations légales

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

Produit(s) apparenté(s)

Réf. du produit
Description
Tarif

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

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

Pictogrammes

Corrosion
GHS05

Mention d'avertissement

Danger

Mentions de danger

H290,H314,H412

Classification des risques

Aquatic Chronic 3 - Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B

Risques supp

EUH071

Classe de danger pour l'eau (WGK)

WGK 3

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable

Faites votre choix parmi les versions les plus récentes :

Certificats d'analyse (COA)

Lot/Batch Number
BCCM0233
BCCL6079
BCCJ8873
BCCH5607
BCCG3065

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Articles

Elemental Impurities - Certified Ref. Materials

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

Elemental Impurities - Certified Ref. Materials

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

Elemental Impurities - Certified Ref. Materials

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

Elemental Impurities - Certified Ref. Materials

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

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