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07368

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元素杂质混标3,符合ICH Q3D注射用

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

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About This Item

分類程式碼代碼:
41116107
NACRES:
NA.24

等級

certified reference material
TraceCERT®

品質等級

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, 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 )

技術

ICP: suitable

格式

multi-component solution

一般說明

该认证标准物质(CRM)根据ISO/IEC 17025ISO 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。
请访问http://www.sigma-aldrich.com下载您的证书。

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

象形圖

CorrosionExclamation mark

訊號詞

Danger

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

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


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文章

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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.

Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources

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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