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Merck
CN
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主要文件

07368

Supelco

符合ICH Q3D肠外、皮肤和透皮给药途径的元素杂质标准品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

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About This Item

UNSPSC代码:
41116107
NACRES:
NA.24

等级

certified reference material
TraceCERT®

质量水平

Agency

according to ICH Q3D
according to Ph. Eur.
according to USP

产品线

TraceCERT®

保质期

limited shelf life, expiry date on the label

组成

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

浓度

in nitric acid and hydrofluoric acid (5% nitric acid and <0.5% hydrofluoric acid )

技术

ICP: suitable

包装形式

multi-component solution

一般描述

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.

应用

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.

制备说明

为制备这种CRM,仅可使用最高纯度的材料。

其他说明

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.

法律信息

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

象形图

CorrosionExclamation mark

警示用语:

Danger

危险分类

Acute Tox. 4 Dermal - Acute Tox. 4 Oral - Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B

补充剂危害

储存分类代码

8B - Non-combustible corrosive hazardous materials

WGK

WGK 1

闪点(°F)

Not applicable

闪点(°C)

Not applicable


历史批次信息供参考:

分析证书(COA)

Lot/Batch Number

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商品

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

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