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1.06520 SAFC

Sodium iodide

EMPROVE® ESSENTIAL Ph Eur,BP,JP,USP

Synonym: Sodium iodide

  • CAS Number 7681-82-5

  • Empirical Formula (Hill Notation) INa

  • Molecular Weight 149.89

  •  MDL number MFCD00003532

  •  EC Index Number 231-679-3

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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
vapor pressure   1 hPa ( 767 °C)
product line   Emprove® Essential
potency   4340 mg/kg LD50, oral (Rat)
pH   6-9 (20 °C, 50 g/L in H2O)
bp   1304 °C/1013 hPa
mp   659 °C
density   3.67 g/cm3 at 20 °C
bulk density   1500‑2000 kg/m3
InChI   1S/HI.Na/h1H;/q;+1/p-1
InChI key   FVAUCKIRQBBSSJ-UHFFFAOYSA-M
storage conditions   Store at +5°C to +30°C.

Description

Analysis Note

Assay (argentometric; calculated on dried substance): 99.0 - 100.5 %
Identity: passes test
Appearance of solution: passes test
Appearance of solution (JP): passes test
Alkaline reacting substances: passes test
Chloride, Bromide and Thiosulfate: passes test
Cyanide (CN): passes tes
Iodate(IO₃): passes test
Sulfate (SO₄): ≤ 0.005 %
Thiosulfate (S₂O₃): passes test
Thiosulfate and barium: passes test
Total nitrogen (N): ≤ 0.001 %
Heavy metals (as Pb): ≤ 0.001 %
As (Arsenic): ≤ 0.0003 %
Fe (Iron): ≤ 0.0002 %
K (Potassium): passes test
Residual solvents (Ph Eur/USP/ICH) class 3: ≤ 0.5 %
Other residual solvents(Ph Eur/USP/ICH): excluded by manufacturing process
Loss on drying (120 °C): ≤ 3.0 %
Water: ≤ 2.0 %
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 in indicated (*).
conforms to Ph Eur, BP, JP, USP

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