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Key Documents

69729

Supelco

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

Sinónimos:

ICH Q3D oral elemental impurities

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About This Item

UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
TraceCERT®

Quality Level

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, 140 mg/L
Cr, 1100 mg/L
Cu, 300 mg/L
Li, 55 mg/L
Mo, 300 mg/L
Sb, 120 mg/L
Sn, 600 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

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

  • ICH Q3D elemental impurities testing guidelines: A study conducted rapid screening of pharmaceutical products for elemental impurities using a high-resolution portable energy dispersive X-ray fluorescence spectrometer. This method adheres to ICH Q3D guidelines for oral dosage forms, offering an efficient tool for routine quality control in pharmaceutical manufacturing (Zhu et al., 2023).
  • Elemental impurity analysis for pharmaceuticals: Research focused on the human health risk assessment of total chromium impurities in cough syrups. This study aligns with ICH Q3D regulations, emphasizing the need for rigorous testing of oral pharmaceuticals to ensure consumer safety, particularly regarding the toxic potential of elemental impurities (Jurowski and Krosniak, 2024).
  • Pharmaceutical trace metal contamination standards: The determination of ICH-Q3D elemental impurity leachables in glass vials was explored using Inductively Coupled Plasma Mass Spectrometry (ICP-MS). This research underscores the importance of assessing leachable heavy metals in drug packaging to prevent contamination of oral drug products (Breckenridge et al., 2023).

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

pictograms

CorrosionExclamation mark

signalword

Danger

Hazard Classifications

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

supp_hazards

Storage Class

8B - Non-combustible corrosive hazardous materials

wgk_germany

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable


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Artículos

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.

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.

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