69729

ICH Q3D口服药元素杂质混标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

• 别名: ICH Q3D oral elemental impurities
• 分類程式碼代碼: 41116107
• NACRES: NA.24

属性

• 等級: certified reference material; TraceCERT^®
• 品質等級: 300
• agency: according to ICH Q3D; according to Ph. Eur.; according to USP
• 產品線: TraceCERT^®
• 儲存期限: limited shelf life, expiry date on the label
• 成份: 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
• 濃度: in nitric acid and hydrofluoric acid (5% nitric acid and <0.5% hydrofluoric acid )
• 技術: ICP: suitable
• 形式: multi-component solution

说明

一般說明

该认证标准物质（CRM）根据ISO/IEC 17025和ISO 17034生产和认证。该 CRM 可追溯到 SI 单位千克，并根据 NMI 中的主要材料（例如 NIST）进行测量。
认证内容包括标识在证书上的不确定性和有效期。
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應用

• 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).

準備報告

为制备这种CRM，仅可使用最高纯度的材料。

法律資訊

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

安全信息

• 象形圖: GHS05,GHS07
• 訊號詞: Danger
• 危險聲明: H290,H302 + H312,H314
• 防範說明: P234 - P280 - P301 + P312 - P303 + P361 + P353 - P304 + P340 + P310 - P305 + P351 + P338
• 危險分類: Acute Tox. 4 Dermal - Acute Tox. 4 Oral - Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B
• 安全危害: EUH071
• 儲存類別代碼: 8B - Non-combustible corrosive hazardous materials
• 水污染物質分類（WGK）: WGK 1
• 閃點（°F）: Not applicable
• 閃點（°C）: Not applicable