产品名称
氢氧化钠溶液，10 mol/L, EMPROVE® EXPERT
vapor pressure
3 mmHg ( 37 °C)
Quality Level
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
存储类别
8B - Non-combustible corrosive hazardous materials
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商品
See how a global-local manufacturing model ensures reliable and consistent supply of high-quality process liquids and buffers for biomanufacturing.
全球贸易项目编号
| 货号 | GTIN |
|---|---|
| 4.80648.2500 | 04027269983543 |
| 4.80648.9950 | 04027269983574 |
| 4.80648.9025 | 04027269983550 |