1.00233
Sodium hydroxide solution 0,25 mol/L
EMPROVE® EXPERT
Pharma Manufacturing
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About This Item
UNSPSC Code:
12352305
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 (*).
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
Signal Word
Warning
Hazard Statements
Precautionary 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
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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