Analysis Note
Assay (alkalimetric):
9.5 - 10.0 %
: 10.0 - 10.5 % (w/v)
Identity: passes test
Color: ≤ 10 Hazen
Appearance: passes test
Bromide or iodide: passes test
Free bromine or chlorine: passes test
Free chlorine (Cl): ≤ 0.0001
Sulfate (SO₄): ≤ 0.0005 %
Sulphite (SO3): ≤ 0.001 %
Heavy metals (as Pb): ≤ 0.0001 %
As (Arsenic): ≤ 0.000015 %
Hg (Mercury): ≤ 0.0000010 %
Residual solvents (ICH Q3C): ...excluded by production process
Evaporation residue: ≤ 0.01
Residue on ignition (as SO₄): ≤ 0.008 %
Endotoxins: ≤ 2.5 I.U./ml
Lotnumber (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 (*).
Corresponds to Ph Eur, JP, NF
Legal Information
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
- UPC:
- 51281513
- Condition:
- New
- Weight:
- 1.00 Ounces
- HazmatClass:
- No
- WeightUOM:
- LB
- MPN:
- 4805922500
