07368

Elemental Impurities according to ICH Q3D parenteral, cutaneous and transcutaneous, 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

• 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: Ba, 70 mg/L ; Cr, 110 mg/L ; Cu, 30 mg/L ; Li, 25 mg/L ; Mo, 150 mg/L ; Sb, 9 mg/L ; Sn, 60 mg/L
• 濃度: in nitric acid and hydrofluoric acid (5% nitric acid and <0.5% hydrofluoric 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 in accordance with ISO 17034 and characterized in accordance with ISO/IEC 17025. This CRM is traceable to SI unit kg and measured against primary material from a National Metrology Institute (NMI), e.g. NIST.

Please visit ISO certificates and Site Quality Self-Assessments to access the current certificates of accreditation.

Download your certificate at https://www.sigma-aldrich.com to view certified values, including uncertainty, date of expiry, and detailed information about trace impurities.

アプリケーション

Elemental Impurities according to ICH Q3D parenteral, Standard 3 may be used as a reference standard for screening of elemental impurities in pharmaceutical products in compliance with United States Pharmacopoeia (USP) and ICH-Q3D.[1]

調製ノート

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

その他情報

We provide a diverse range of certified reference materials, including various elemental impurity mixes and single elements, with concentration limits that comply with ICH Q3D guidelines. For more information please visit our Inorganic Elemental Impurity Mix Standards

In our effort to be more sustainable, we′re going digital with COAs-download them directly from our website.

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,GHS07
• シグナルワード: Danger
• 危険有害性情報: H290,H302 + H312,H314
• 注意書き: P234 - P280 - P301 + P312 - P303 + P361 + P353 - P304 + P340 + P310 - P305 + P351 + P338
• 危険有害性の分類: Acute Tox. 4 Dermal - Acute Tox. 4 Oral - Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B
• 補足的ハザード: EUH071
• 保管分類コード: 8B - Non-combustible corrosive hazardous materials
• WGK: WGK 1
• 引火点(°F): Not applicable
• 引火点(℃): Not applicable