4.80763
Sodium hydroxide solution
8 M, EMPROVE® EXPERT
Pharma Manufacturing
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About This Item
UNSPSC Code:
12352305
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product name
Sodium hydroxide solution 8 mol/L, 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 (acidimetric,NaOH)7.9 - 8.1 mol/l
Carbonate (as Na₂CO₃)≤ 1.0 %
Chloride (Cl)≤ 50 ppm
Sulfate (SO₄)≤ 30 ppm
Heavy metals (as Pb)≤ 5.0 ppm
Al (Aluminium)≤ 10 ppm
Fe (Iron)≤ 3 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 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 (*).
Carbonate (as Na₂CO₃)≤ 1.0 %
Chloride (Cl)≤ 50 ppm
Sulfate (SO₄)≤ 30 ppm
Heavy metals (as Pb)≤ 5.0 ppm
Al (Aluminium)≤ 10 ppm
Fe (Iron)≤ 3 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 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
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Description
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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)
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