General description
Every bio-manufacturing process involves buffer preparation, pH adjustment, and cleaning. All our respective GMP (IPEC/EXCiPACT) products are manufactured under Excipient GMP conditions and feature low bioburden levels, backed by our Emprove® Program for exceptional quality and documentation support.
As a result, you can integrate our products directly into your biopharmaceutical production process. In addition to our comprehensive portfolio, we also offer custom manufacturing services to meet your exact needs.
As a result, you can integrate our products directly into your biopharmaceutical production process. In addition to our comprehensive portfolio, we also offer custom manufacturing services to meet your exact needs.
Application
- As a base for preparing various process buffers.
- Used to adjust the pH of process solutions, buffers, and media in upstream and downstream processing.
- Acts as a cleaning-in-place (CIP) agent for equipment, piping, and vessels due to its strong alkaline properties and low levels of metal impurities.
- Minimizes iron contamination, reducing oxidation risk and interference with downstream purification and analytical steps.
Features and Benefits
- Comprehensive, up-to-date documentation you need to navigate regulatory challenges, manage risks, and improve processes.
- Suitable for higher-risk applications where the lowest microbiological and endotoxin levels are of utmost importance.
- Emprove® products are designed to facilitate compliance with global regulations (e.g., ICH Q7, EU GMP, USP, EP).
- Detailed supply chain and manufacturing information helps ensure traceability and continuity, which is critical for GMP manufacturing.
Legal Information
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
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Danger
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Hazard Classifications
Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1A
保管分類
8B - Non-combustible corrosive hazardous materials
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WGK 1
適用法令
試験研究用途を考慮した関連法令を主に挙げております。化学物質以外については、一部の情報のみ提供しています。 製品を安全かつ合法的に使用することは、使用者の義務です。最新情報により修正される場合があります。WEBの反映には時間を要することがあるため、適宜SDSをご参照ください。
劇物
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名称等を表示すべき危険物及び有害物
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名称等を通知すべき危険物及び有害物
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試験成績書(COA)
製品のロット番号・バッチ番号を入力して、試験成績書(COA) を検索できます。ロット番号・バッチ番号は、製品ラベルに「Lot」または「Batch」に続いて記載されています。
