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

• 別名: ICH Q3D Elemental Impurity Analysis Standard
• UNSPSCコード: 41116107
• NACRES: NA.24

特性

• グレード: certified reference material; TraceCERT^®
• 品質水準: 300
• 認証: according to ICH Q3D; according to Ph. Eur.; according to USP
• 製品種目: TraceCERT^®
• シェルフライフ: limited shelf life, expiry date on the label
• 組成: Ag, 10 mg/L ; As, 15 mg/L ; Cd, 2 mg/L ; Co, 5 mg/L ; Hg, 3 mg/L ; Ni, 20 mg/L ; Pb, 5 mg/L ; Se, 80 mg/L ; Tl, 8 mg/L ; V, 10 mg/L
• 濃度: (in 12% nitric acid)
• テクニック: ICP: suitable
• フォーマット: multi-component solution

詳細

詳細

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.

アプリケーション

• Application of ICH Guidelines for the Assessment and Control of Elemental Impurities in Parecoxib Sodium by Graphite-Digestion and ICP-MS: This research demonstrates the application of ICH Q3D guidelines for evaluating elemental impurities in parenteral formulations, specifically using graphite-digestion and ICP-MS techniques on Parecoxib Sodium. This approach ensures compliance with pharmaceutical safety standards, emphasizing its critical role in maintaining drug quality and patient safety (Hao et al., 2022).

調製ノート

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

法的情報

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

安全性情報

• ピクトグラム: GHS05
• シグナルワード: Danger
• 危険有害性情報: H290,H314
• 注意書き: P234 - P280 - P303 + P361 + P353 - P304 + P340 + P310 - P305 + P351 + P338 - P363
• 危険有害性の分類: Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B
• 補足的ハザード: EUH071
• WGK: WGK 2