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重要文件

73108

Supelco

ICH Q3D口服药元素杂质混标2

TraceCERT®, (in 10% hydrochloric acid), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

同義詞:

ICH Q3D Elemental Impurity Analysis

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About This Item

分類程式碼代碼:
41116107
NACRES:
NA.24
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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, 100 mg/L
Ir, 100 mg/L
Os, 100 mg/L
Pd, 100 mg/L
Pt, 100 mg/L
Rh, 100 mg/L
Ru, 100 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.

準備報告

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

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

CorrosionExclamation mark

訊號詞

Warning

危險聲明

危險分類

Met. Corr. 1 - Skin Irrit. 2 - STOT SE 3

標靶器官

Respiratory system

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

利用分析方法和材料控制藥品中的元素雜質,以確保病患安全。

Control elemental impurities in drug products with analytical methods and materials to ensure patient safety.

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