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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

别名:

ICH Q3D Elemental Impurity Analysis

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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

300

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

相关类别

一般說明

This certified reference material (CRM) is produced and certified in accordance with ISO/IEC 17025 and ISO 17034. This CRM is traceable to SI unit kg and measured against primary material from an NMI, e.g. NIST.
Certified content incl. uncertainty and expiry date are given on the certificate.
Download your certificate at: http://www.sigma-aldrich.com.

準備報告

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

法律資訊

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

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产品编号
说明
价格

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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

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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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元素杂质混标1，符合ICH Q3D注射用, (in 12% nitric acid), TraceCERT®, applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

象形圖

CorrosionExclamation mark
GHS05,GHS07

訊號詞

Warning

危險聲明

H290,H315,H335

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

历史批次信息供参考:

分析证书(COA)

Lot/Batch Number

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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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