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Merck
모든 사진(1)

주요 문서

19041

Supelco

Elemental Impurities according to ICH Q3D oral, Standard 1

TraceCERT®, (in 12% nitric acid), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

동의어(들):

TraceCERT Elemental Impurities according to ICH Q3D oral

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About This Item

UNSPSC 코드:
41116107
NACRES:
NA.24

Grade

certified reference material

Quality Level

Agency

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

제품 라인

TraceCERT®

grade

TraceCERT®

유통기한

limited shelf life, expiry date on the label

구성

Ag, 150 mg/L
As, 15 mg/L
Cd, 5 mg/L
Co, 50 mg/L
Hg, 30 mg/L
Ni, 200 mg/L
Pb, 5 mg/L
Se, 150 mg/L
Tl, 8 mg/L
V, 100 mg/L

농도

(in 12% nitric acid)

기술

ICP: suitable

형식

multi-component solution

일반 설명

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.

제조 메모

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

기타 정보

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.

법적 정보

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

면책조항

For U.S. Customers: Contains mercury; Do not place in trash - dispose according to local, state, or federal laws.

픽토그램

Corrosion

신호어

Danger

유해 및 위험 성명서

Hazard Classifications

Aquatic Chronic 3 - Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B

보충제 위험성

WGK

WGK 3

Flash Point (°F)

Not applicable

Flash Point (°C)

Not applicable


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시험 성적서(COA)

Lot/Batch Number

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문서 라이브러리 방문

문서

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.

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.

자사의 과학자팀은 생명 과학, 재료 과학, 화학 합성, 크로마토그래피, 분석 및 기타 많은 영역을 포함한 모든 과학 분야에 경험이 있습니다..

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