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1.08882 SAFC

Zinc sulfate monohydrate

EMPROVE® ESSENTIAL Ph Eur,USP

Synonym: Sulfuric acid zinc salt monohydrate, Zinc sulfate monohydrate

  • CAS Number 7446-19-7

  • Empirical Formula (Hill Notation) O4SZn · xH2O

  • Molecular Weight 161.45 (anhydrous basis)

  •  MDL number MFCD00149893

  •  EC Index Number 231-793-3

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Excipients, Mineral Salts, Solid Dosage Forms More...
Agency/Method   Ph. Eur.
  USP
Quality Level   500
product line   Emprove® Essential
pH   4.0-5.6 (20 °C, 50 g/L in H2O)
solubility   350 g/L (anhydrous substance)
density   3.2 g/cm3 at 20 °C
bulk density   500 kg/m3
InChI   1S/H2O4S.H2O.Zn/c1-5(2,3)4;;/h(H2,1,2,3,4);1H2;/q;;+2/p-2
InChI key   RNZCSKGULNFAMC-UHFFFAOYSA-L
storage conditions   Store at +5°C to +30°C.

Description

General description

EMPROVE® ESSENTIAL Ph Eur,USP

Analysis Note

Assay (complexometric)99.0 - 100.5 %Identitypasses testAppearance of solutionpasses testFree acidpasses testpH-value (5 %; water)4.0 - 5.6Chloride (Cl)≤ 0.005 %As (Arsenic)≤ 0.0003 %Cd (Cadmium) (*)≤ 0.0002 %Cr (Chromium)≤ 0.0005 %Fe (Iron)≤ 0.003 %Hg (Mercury)≤ 0.0005 %Ni (Nickel) (*)≤ 0.0005 %Pb (Lead) (*)≤ 0.001 %Se (Selenium)≤ 0.003 %Alkali- and alkaline earth metals (as sulfate)≤ 0.5 %Residual solvents (ICH Q3C)excluded by manufacturing processLoss on Drying (105 °C)≤ 1.0 %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., USP

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