Sodium hydroxide solution

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.

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.

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 (*).

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