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1.08846 SAFC

Zinc oxide

EMPROVE® ESSENTIAL Ph Eur,BP,JP,USP

Synonym: Zinc oxide

  • CAS Number 1314-13-2

  • Empirical Formula (Hill Notation) OZn

  • Molecular Weight 81.39

  •  MDL number MFCD00011300

  •  EC Index Number 215-222-5

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Excipients, Liquid Dosage Forms, Mineral Salts,
Agency/Method   BP
  JP
  Ph. Eur.
  USP
Quality Level   500
product line   Emprove® Essential
potency   >5000 mg/kg LD50, oral (Rat)
pH   7 (20 °C, 50 g/L in H2O, slurry)
mp   1975 °C
density   5.61 g/cm3 at 20 °C
bulk density   200‑700 kg/m3
InChI   1S/O.Zn
InChI key   XLOMVQKBTHCTTD-UHFFFAOYSA-N
storage conditions   Store at +5°C to +30°C.

Description

Analysis Note

Assay (complexometric, ZnO calculated on ignited substance): 99.0 - 100.5 %
Identity: passes test
Carbonate and color of solution: passes test
Free Alkali: passes test
Chloride (Cl): ≤ 0.005 %
Sulfate (SO₄): ≤ 0.02 %
As (Arsenic): ≤ 0.0005 %
Cd (Cadmium)*: ≤ 0.001 %
Fe (Iron): ≤ 0.001 %
Pb (Lead)*: ≤ 0.005 %
Tl (Thallium)*: ≤ 0.0005 %
Iron and other heavy metals: passes test
Residual solvents (Ph Eur/USP/ICH): excluded by manufacturing process
Loss on ignition (850 °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 (*).
conforms to Ph Eur, BP, JP,USP

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