4.80659
Sodium hydroxide solution
25% (low iron), EMPROVE® EXPERT
Pharma Manufacturing
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product name
Sodium hydroxide solution 25% low iron, EMPROVE® EXPERT
Quality Level
product line
EMPROVE® EXPERT
form
liquid
pH
14 (20 °C in H2O)
density
1.28 g/cm3 at 20 °C
storage temp.
no temp limit
General description
EMPROVE® EXPERT
Analysis Note
Assay (total alkalinity calc. as NaOH)24.8 - 25.2 %Identitypasses testAppearance of solutionpasses testCarbonate (as Na₂CO₃)≤ 0.6 %Chloride (Cl)≤ 50 ppmSulfate (SO₄)≤ 30 ppmHeavy metals (as Pb)≤ 5 ppmAl (Aluminium)≤ 10 ppmFe (Iron)≤ 1.0 ppmResidual solvents (ICH Q3C)...excluded by production processFiltered 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 (*).
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
Product No.
Description
Pricing
Signal Word
Danger
Hazard Statements
Precautionary 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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