製品名
水酸化ナトリウム 溶液, EMPROVE® EXPERT
vapor pressure
3 mmHg ( 37 °C)
Quality Segment
product line
EMPROVE® EXPERT
assay
((acidimetric, NaOH)- 9.9-10.1 mol/l), 29.9-30.3% (acidimetric)
form
liquid
concentration
29.9-30.3% (acidimetric)
impurities
≤1.0% Carbonate (as Na2CO3), ≤10 ppm AI (Aluminium), ≤2.00 ppm Ni (Nickel)*, ≤3 ppm Fe (Iron)*, ≤30 ppm Sulfate (S04), ≤60 ppm Chloride (Cl)
pH
14 (20 °C in H2O)
solubility
water: soluble at 20 °C
density
1.33 g/cm3 at 20 °C
application(s)
cleaning in place
pharma/biopharma processes
storage temp.
15-25°C
SMILES string
[OH-].[Na+]
InChI
1S/Na.H2O/h;1H2/q+1;/p-1
InChI key
HEMHJVSKTPXQMS-UHFFFAOYSA-M
General description
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
- To adjust the pH of process solutions, buffers, and media.
- As a base for preparing various process buffers.
- As a CIP solution to clean stainless-steel tanks and piping systems, to wash and store chromatography resins, and to regenerate membranes.
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.
Analysis Note
Assay (acidimetric): 29.9 - 30.3 %
Identity: passes test
Carbonate (as Na₂CO₃): ≤ 1.0 %
Chloride (Cl): ≤ 60 ppm
Sulfate (SO₄): ≤ 30 ppm
Heavy metals (as Pb): ≤ 5.0 ppm
Al (Aluminium): ≤ 10 ppm
Fe (Iron): ≤ 3 ppm
Ni (Nickel) *: ≤ 2.00 ppm
Residual solvents (ICH Q3C): ...excluded by production process
Filtered with 0.2 µm
This product has been manufactured from Sodium hydroxide pellets Ph Eur, BP, JP, NF and water for injection (wfi) acc. USP which conforms with highly purified water (hpw) acc. Ph Eur.
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Legal Information
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signalword
Danger
hcodes
Hazard Classifications
Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1A
保管分類
8B - Non-combustible corrosive hazardous materials
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
pdsc
名称等を表示すべき危険物及び有害物
ishl_indicated
名称等を通知すべき危険物及び有害物
ishl_notified
Emprove®プログラムを使用してGMPを遵守します。
Emprove® Dossiersで資格認定を加速し、コンプライアンスを維持し、時間を節約しましょう。
注意: EmproveSuite.comに移動します。ユーザー名とパスワードはSigmaAldrich.comとは別のもので、異なる場合があります。
無料会員登録すると、数分でEmprove® Dossiersにアクセスできます。 購読プランをアップグレードして、Emprove® Suiteの高度でカスタマイズされたコンテンツをアンロックしてください。
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