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07368

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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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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

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

濃度

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

技術

ICP: suitable

形式

multi-component solution

相關類別

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.

應用

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.

準備報告

为制备这种CRM，仅可使用最高纯度的材料。

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

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73108

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

69729

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

Danger

危險分類

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

安全危害

EUH071

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

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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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