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Merck
CN
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主要文件

89922

Supelco

元素杂质混标2,符合ICH Q3D注射用

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

别名:

ICH Q3D Elemental Impurity Standard 2

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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

Au, 100 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

浓度

(in 10% hydrochloric 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.

Search & download your certificate here.

应用

Elemental Impurities according to ICH Q3D parenteral can be used as calibration standard for quantitation of elemental impurities in tablets according to the new USP chapters <232> Elemental Impurities – Limits and <233> Elemental Impurities by ICP-OES method.

制备说明

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

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

Corrosion

警示用语:

Warning

危险声明

预防措施声明

危险分类

Met. Corr. 1

储存分类代码

8B - Non-combustible corrosive hazardous materials

WGK

WGK 1


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