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Merck
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문서

07368

Supelco

Elemental Impurities according to ICH Q3D parenteral, Standard 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

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

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

농도

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

기술

ICP: suitable

형식

multi-component solution

일반 설명

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.

제조 메모

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

법적 정보

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

픽토그램

CorrosionExclamation mark

신호어

Danger

유해 및 위험 성명서

Hazard Classifications

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

보충제 위험성

Storage Class Code

8B - Non-combustible, corrosive hazardous materials

WGK

WGK 1

Flash Point (°F)

Not applicable

Flash Point (°C)

Not applicable


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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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