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Quality Level
product line
EMPROVE® EXPERT
form
liquid
pH
<1 (20 °C in H2O)
density
1.03 g/cm3 at 20 °C
storage temp.
2-25°C
Related Categories
General description
EMPROVE® EXPERT
Packaging
1 l
Analysis Note
Concentration (HCl)1.8 - 2.2 mol/lIdentitypasses testColor≤ 10 HazenAppearancepasses testFree Bromine or Free Chlorinepasses testFree chlorine (Cl)≤ 0.0001Sulfate (SO₄)≤ 0.0005 %Sulfite (SO₃)≤ 0.001 %Heavy metals (as Pb)≤ 0.0001 %As (Arsenic)≤ 0.00015 %Residual solvents (ICH Q3C)...excluded by production processResidue on ignition (as SO₄)≤ 0.008 %Evaporation residue≤ 0.010 %Endotoxins≤ 0.25 I.U./mlLotnumber (raw material)Filtered with 0.2 µm
Manufactured from Hydrochloric acid fuming 37% EMPROVE® ESSENTIAL PhEur, BP, JP, NF and purified water acc. PhEur, JP.
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 (*).
Manufactured from Hydrochloric acid fuming 37% EMPROVE® ESSENTIAL PhEur, BP, JP, NF and purified water acc. PhEur, JP.
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
Met. Corr. 1
Storage Class Code
8B - Non-combustible, corrosive hazardous materials
WGK
WGK 1
Flash Point(F)
Not applicable
Flash Point(C)
Not applicable
Certificate of Analysis
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Certificate of Quality
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Certificates
What is the Emprove® Program?
The Emprove® Program is a system providing comprehensive and thorough documentation of our filters and single-use components, pharma raw materials, and starting materials.
Material Qualification Dossier
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Quality Management Dossier (Open Access)
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Operational Excellence Dossier
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Emprove® Dossiers contain information intended to support the registration process and risk assessment activities of pharmaceutical producers and contain confidential information. Please contact us if you would like access.Our team of scientists has experience in all areas of research including Life Science, Material Science, Chemical Synthesis, Chromatography, Analytical and many others.
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