Skip to Content
Merck
All Photos(1)

Documents

07368

Supelco

Elemental Impurities according to ICH Q3D parenteral, 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

Sign Into View Organizational & Contract Pricing
All Photos(1)

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

Ba, 70 mg/L
Cr, 110 mg/L
Cu, 30 mg/L
Li, 25 mg/L
Mo, 150 mg/L
Sb, 9 mg/L
Sn, 60 mg/L

concentration

in nitric acid and hydrofluoric acid (5% nitric acid and <0.5% hydrofluoric 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.

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

related product

Product No.
Description
Pricing

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

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

CorrosionExclamation mark
GHS05,GHS07

Signal Word

Danger

Hazard Statements

H290 - H302 + H312 - H314

Hazard Classifications

Acute Tox. 4 Dermal - Acute Tox. 4 Oral - Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B

Supplementary Hazards

EUH071

Storage Class Code

8B - Non-combustible, corrosive hazardous materials

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Choose from one of the most recent versions:

Certificates of Analysis (COA)

Lot/Batch Number
BCCJ4380
BCCG4084
BCCF7105
BCCF2116
BCCC7220

Don't see the Right Version?

If you require a particular version, you can look up a specific certificate by the Lot or Batch number.

Search for a COA

Already Own This Product?

Find documentation for the products that you have recently purchased in the Document Library.

Visit the Document Library

Articles

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.

Our team of scientists has experience in all areas of research including Life Science, Material Science, Chemical Synthesis, Chromatography, Analytical and many others.

Contact Technical Service