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
Synonyme(s) :
ICH Q3D Elemental Impurity Standard 2
About This Item
Produits recommandés
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
Au, 100 mg/L
Ir, 10 mg/L
Os, 10 mg/L
Pd, 10 mg/L
Pt, 10 mg/L
Rh, 10 mg/L
Ru, 10 mg/L
Concentration
(in 10% hydrochloric acid)
Technique(s)
ICP: suitable
Format
multi-component solution
Description générale
Certified content incl. uncertainty and expiry date are given on the certificate.
Download your certificate at: http://www.sigma-aldrich.com.
Application
<li><strong>Determination of ICH-Q3D Elemental Impurity Leachables in Glass Vials:</strong> This study applies inductively coupled plasma mass spectrometry to assess ICH-Q3D elemental impurity leachables in glass vials used for parenteral applications, providing a crucial methodology for ensuring compliance with pharmaceutical heavy metal analysis standards (Breckenridge et al., 2023).</li>
<li><strong>Application of ICH Guidelines for Assessment and Control of Elemental Impurities in Parecoxib Sodium:</strong> Utilizing graphite-digestion and ICP-MS, this research conforms to the ICH Q3D guidelines for evaluating elemental impurities in parecoxib sodium, highlighting a robust approach for elemental impurity analysis in injectable pharmaceuticals (Hao et al., 2022).</li>
<li><strong>Risk-Based Approach to Evaluate and Control Elemental Impurities in Therapeutic Proteins:</strong> This study introduces a risk-based strategy for the assessment and control of elemental impurities in therapeutic proteins, which aligns with the requirements of USP <232> <233> compliance and aids in the development of safer parenteral medications (Luo et al., 2020).</li>
<li><strong>Assessment of Extractable Elements from Elastomers:</strong> Investigating the potential for elemental impurities to leach from elastomers, this research is vital for the risk assessment of elemental contaminants in parenteral formulations, ensuring safety and compliance with ICH Q3D standards (Paskiet et al., 2019).</li>
</ul>
Notes préparatoires
Informations légales
Produit(s) apparenté(s)
Mention d'avertissement
Warning
Mentions de danger
Conseils de prudence
Classification des risques
Met. Corr. 1
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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Control elemental impurities in drug products with analytical methods and materials to ensure patient safety.
Control elemental impurities in drug products with analytical methods and materials to ensure patient safety.
Control elemental impurities in drug products with analytical methods and materials to ensure patient safety.
Control elemental impurities in drug products with analytical methods and materials to ensure patient safety.
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