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
About This Item
Produits recommandés
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Qualité
certified reference material
TraceCERT®
Niveau de qualité
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
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
Catégories apparentées
Description générale
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).
Notes préparatoires
Informations légales
Produit(s) apparenté(s)
Mention d'avertissement
Danger
Mentions de danger
Classification des risques
Acute Tox. 4 Dermal - Acute Tox. 4 Oral - Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B
Risques supp
Code de la classe de stockage
8B - Non-combustible, corrosive hazardous materials
Classe de danger pour l'eau (WGK)
WGK 1
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Articles
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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