产品名称
32% 氢氧化钠溶液, EMPROVE® EXPERT
Quality Segment
vapor pressure
3 mmHg ( 37 °C), 8 hPa ( 20 °C)
product line
EMPROVE® EXPERT
assay
10.0-10.5% (w/v), 9.5-10.0% (alkalimetric)
form
liquid
impurities
≤1.0% Carbonate (as Na₂CO₃), ≤10 ppm Al (Aluminium), ≤2.00 ppm Ni (Nickel)*, ≤30 ppm Sulfate (SO₄), ≤4 ppm Fe (Iron), ≤70 ppm Chloride (Cl)
pH
14 (20 °C in H2O)
mp
9 °C
density
1.35 g/cm3 at 20 °C
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
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
Sodium hydroxide (NaOH) is an inorganic highly caustic metallic base and can readily absorb moisture in the air. It can be used:
- As a base for preparing various process buffers.
- To adjust the pH of process solutions, buffers, and media.
- 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): 32.0 - 33.0 %
Carbonate (as Na₂CO₃): ≤ 1.0 %
Chloride (Cl): ≤ 70 ppm
Sulfate (SO₄): ≤ 30 ppm
Heavy metals (as Pb): ≤ 5.0 ppm
Al (Aluminium): ≤ 10 ppm
Fe (Iron): ≤ 4ppm
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 waterfor 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 (*).
Carbonate (as Na₂CO₃): ≤ 1.0 %
Chloride (Cl): ≤ 70 ppm
Sulfate (SO₄): ≤ 30 ppm
Heavy metals (as Pb): ≤ 5.0 ppm
Al (Aluminium): ≤ 10 ppm
Fe (Iron): ≤ 4ppm
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 waterfor 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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hcodes
存储类别
8B - Non-combustible corrosive hazardous materials
signalword
Danger
Hazard Classifications
Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1A
wgk
WGK 1
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