4.80648

Sodium hydroxide solution

10 M EMPROVE^® EXPERT

• Synonim(y): NaOH, Sodium hydroxide liquid, Sodium hydroxide solution
• Wzór liniowy: NaOH
• Numer CAS: 1310-73-2
• Masa cząsteczkowa: 40.00
• UNSPSC Code: 12352305
• MDL number: MFCD00003548

Właściwości

• Nazwa produktu: Sodium hydroxide solution 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; 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

Opis

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

Assay (acidimetric,NaOH): 9.9 - 10.1 mol/l
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

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

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Informacja o środkach bezpieczeństwa

• pictograms: GHS05
• signalword: Danger
• hcodes: H290,H314
• pcodes: P234 - P280 - P303 + P361 + P353 - P304 + P340 + P310 - P305 + P351 + P338 - P363
• Hazard Classifications: Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1A
• Klasa składowania: 8B - Non-combustible corrosive hazardous materials