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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

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

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

格式

multi-component solution

相關類別

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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ICH Q3D口服药元素杂质混标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

89922

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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元素杂质混标3，符合ICH Q3D注射用, 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

從最近期的版本中選擇一個：

分析證明 (COA)

Lot/Batch Number
BCCK6238
BCCJ7676
BCCH3725
BCCG5467
BCCF9648

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文章

Elemental Impurities - Certified Reference Materials for ICH Q3D, USP 232, USP 2232, and Ph.Eur. 5.20

Elemental impurities in drug products pose a risk to patient health due to toxicological effects, and their levels should be controlled within acceptable limits. Find analytical methods and materials for impurity assessment.

Elemental Impurities - Certified Reference Materials for ICH Q3D, USP 232, USP 2232, and Ph.Eur. 5.20

Elemental impurities in drug products pose a risk to patient health due to toxicological effects, and their levels should be controlled within acceptable limits. Find analytical methods and materials for impurity assessment.

Inorganic elemental impurity mixes according to ICH Q3D guidelines

Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources

Inorganic elemental impurity mixes according to ICH Q3D guidelines

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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