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93696

Supelco

ICH Q3D吸入元素杂质混标2

TraceCERT®, (in 10% hydrochloric 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

Au, 10 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

濃度

(in 10% hydrochloric acid)

技術

ICP: suitable

形式

multi-component solution

一般說明

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.

分析報告

The concentrations are 10 fold according to ICH Q3D guideline.

其他說明

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.

法律資訊

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

象形圖

Corrosion

訊號詞

Warning

危險聲明

防範說明

危險分類

Met. Corr. 1

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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分析證明 (COA)

Lot/Batch Number

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文章

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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