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1.06652 SAFC

Sodium sulfite

EMPROVE® ESSENTIAL Ph Eur,BP,NF,E 221

Synonym: Sodium sulfite

  • CAS Number 7757-83-7

  • Empirical Formula (Hill Notation) Na2O3S

  • Molecular Weight 126.04

  •  MDL number MFCD00003503

  •  E Number E221

  •  EC Index Number 231-821-4

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Antioxidants, Biopharmaceutical Process Development and Manufacturing, Excipients, Liquid Dosage Forms,
Agency/Method   BP
  NF
  Ph. Eur.
Quality Level   500
product line   EMPROVE® Essential
potency   2610 mg/kg LD50, oral (Rat)
pH   8.8-10 (20 °C, 50 g/L in H2O)
mp   >500 °C (decomposition)
solubility   220 g/L
density   2.63 g/cm3 at 20 °C
bulk density   1480 kg/m3
InChI   1S/2Na.H2O3S.7H2O/c;;1-4(2)3;;;;;;;/h;;(H2,1,2,3);7*1H2/q2*+1;;;;;;;;/p-2
InChI key   WMJRPJZQQSSDBU-UHFFFAOYSA-L
storage conditions   Store at +5°C to +30°C.

Description

Application

The specification of the product is part of the Emprove® Material Qualification Dossier and can be found under "General Properties".

Analysis Note

Assay (iodometric): 95.0 - 100.5 %
Assay (SO₂): ≥ 48.0 %
Identity: passes test
Appearance of solution: passes test
Thiosulfate (S₂O₃): ≤ 0.05 %
Heavy metals (as Pb): ≤ 0.0005 %
As (Arsenic): ≤ 0.0002 %
Hg (Mercury): ≤ 0.0001 %
Fe (Iron): ≤ 0.0005 %
Pb (Lead): ≤ 0.0002 %
Se (Selenium): ≤ 0.00025 %
Zn (Zinc): ≤ 0.0025 %
Residual solvents (Ph Eur/USP/ICH): excluded by the manufacturing process
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 the purity criteria on food additives according to the current European Commission Regulation.
Conforms to Ph Eur, BP, NF, E221

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

Safety & Documentation

Safety Information

Safety Information for this product is unavailable at this time.

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