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等級
certified reference material
TraceCERT®
品質等級
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
格式
multi-component solution
一般說明
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準備報告
法律資訊
相關產品
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
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
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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 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.
Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources
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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