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Key Documents

4.80648

SAFC

Sodium hydroxide solution 10 mol/L

EMPROVE® EXPERT

Pharma Manufacturing

Synonym(s):

Sodium hydroxide solution

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About This Item

Linear Formula:
NaOH
CAS Number:
Molecular Weight:
40.00
MDL number:
UNSPSC Code:
12352305

vapor pressure

3 mmHg ( 37 °C)

Quality Level

product line

EMPROVE® EXPERT

form

liquid

pH

14 (20 °C in H2O)

density

1.33 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

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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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Pictograms

Corrosion

Signal Word

Danger

Hazard Statements

Hazard Classifications

Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1A

Storage Class Code

8B - Non-combustible, corrosive hazardous materials

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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