4.80648

Sodium hydroxide solution

10 M EMPROVE^® EXPERT

• Synonym(e): Natronlauge, Natriumhydroxid -Lösung
• Lineare Formel: NaOH
• CAS-Nummer: 1310-73-2
• Molekulargewicht: 40.00
• UNSPSC Code: 12352305
• MDL number: MFCD00003548

Eigenschaften

• Produktname: Natriumhydroxidlösung 10 mol/l, EMPROVE^® EXPERT
• vapor pressure: 3 mmHg ( 37 °C)
• Quality Segment: 500
• 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; downstream processes; 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

Beschreibung

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.

Application

Sodium hydroxide (NaOH) is an inorganic highly caustic metallic base and can readily absorb moisture in the air.It can be used:

• 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

Gehalt (acidimetrisch, NaOH): 9,9–10,1 mol/l
Gehalt (acidimetrisch): 29,9–30,3 %
Identität: entspricht
Carbonat (als Na₂CO₃): ≤ 1,0 %
Chlorid (Cl): ≤ 60 ppm
Sulfat (SO₄): ≤ 30 ppm
Schwermetalle (als Pb): ≤ 5,0 ppm
Al (Aluminium): ≤ 10 ppm
Fe (Eisen): ≤ 3 ppm
Ni (Nickel)*: ≤ 2,00 ppm
Lösungsmittelrückstände (ICH Q3C): ...ausgeschlossen durch den Herstellprozess
Filtriert mit 0,2 µm
Dieses Produkt wurde aus Natriumhydroxid-Pellets Ph. Eur., BP, JP, NF und Wasser für Injektionszwecke (wfi) gemäß USP, das Reinstwasser (hpw) nach Ph. Eur. entspricht, hergestellt.
Elementverunreinigungen gemäß der Leitlinie ICH Q3D (Guideline for Elemental Impurities) sind in der Spezifikation berücksichtigt. Elemente der Klassen 1–3 werden nicht oberhalb des Option-1-Limits gemäß ICH Q3D erwartet, wenn diese nicht spezifiziert und gekennzeichnet (*) sind.

Legal Information

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

Sicherheitshinweise

• Piktogramme: GHS05
• Signalwort: Danger
• Gefahrencodes: H290,H314
• Sicherheitshinweise: P234 - P280 - P303 + P361 + P353 - P304 + P340 + P310 - P305 + P351 + P338 - P363
• Hazard Classifications: Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1A
• Lagerklasse: 8B - Non-combustible corrosive hazardous materials