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Key Documents

Safety Information

1.00233

SAFC

Sodium hydroxide solution

0.25 M, EMPROVE® EXPERT

Pharma Manufacturing

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About This Item

UNSPSC Code:
12352305

product name

Sodium hydroxide solution 0,25 mol/L, EMPROVE® EXPERT

Quality Level

product line

EMPROVE® EXPERT

form

liquid

pH

13.5 (20 °C in H2O)

density

1.01 g/cm3 at 20 °C

storage temp.

no temp limit

General description

EMPROVE® EXPERT

Analysis Note

Assay (acidimetric,NaOH)0.23 - 0.27 mol/lCarbonate (as Na₂CO₃)≤ 0.2 %Chloride (Cl)≤ 5 ppmSulfate (SO₄)≤ 30 ppmHeavy metals (as Pb)≤ 5.0 ppmAl (Aluminium)≤ 10 ppmFe (Iron)≤ 3 ppmResidual solvents (ICH Q3C)...excluded by production processEndotoxins≤ 2.0 I.U./mlFiltered 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

also commonly purchased with this product

Pictograms

Corrosion

Signal Word

Warning

Hazard Statements

Hazard Classifications

Eye Irrit. 2 - Met. Corr. 1 - Skin Irrit. 2

Storage Class Code

8A - Combustible, corrosive hazardous materials

WGK

nwg

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

ISHL Indicated Name

Substances Subject to be Indicated Names

ISHL Notified Names

Substances Subject to be Notified Names


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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