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Key Documents

Safety Information

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

Synonym(s):

TraceCERT Elemental Impurities according to ICH Q3D oral

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About This Item

UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
TraceCERT®

Quality Level

300

Agency

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

product line

TraceCERT®

shelf life

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

Related Categories

General description

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).

Preparation Note

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

Legal Information

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

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Pricing

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

Pictograms

Corrosion
GHS05

Signal Word

Danger

Hazard Statements

H290,H314,H412

Hazard Classifications

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

Supplementary Hazards

EUH071

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

PDSCL

Deleterious substance
Poisonous substance

ISHL Indicated Name

Substances Subject to be Indicated Names

ISHL Notified Names

Substances Subject to be Notified Names

JAN Code

19041-BULK:
19041-100ML:4548173916538
19041-100ML-BULK:
19041-VAR:

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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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.

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