69729
Elemental Impurities according to ICH Q3D oral, 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
동의어(들):
ICH Q3D oral elemental impurities
About This Item
추천 제품
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, 140 mg/L
Cr, 1100 mg/L
Cu, 300 mg/L
Li, 55 mg/L
Mo, 300 mg/L
Sb, 120 mg/L
Sn, 600 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
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
기타 정보
In our effort to be more sustainable, we′re going digital with COAs-download them directly from our website.
법적 정보
관련 제품
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
가장 최신 버전 중 하나를 선택하세요:
이미 열람한 고객
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..
고객지원팀으로 연락바랍니다.