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1.06290 SAFC

Sodium benzoate

EMPROVE® ESSENTIAL Ph Eur,BP,NF,FCC,E 211

Synonym: Sodium benzoate

  • CAS Number 532-32-1

  • Empirical Formula (Hill Notation) C7H5NaO2

  • Molecular Weight 144.10

  •  MDL number MFCD00012463

  •  E Number E211

  •  EC Index Number 208-534-8

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Excipients, Liquid Dosage Forms, Preservatives,
Agency/Method   BP
  NF
  Ph. Eur.
Quality Level   500
reg. compliance   FCC
product line   EMPROVE® Essential
autoignition temp.   >500 °C
potency   3140 mg/kg LD50, oral (Rat)
pH   8 (20 °C, 100 g/L in H2O)
mp   436 °C
density   1.50 g/cm3 at 20 °C
bulk density   350 kg/m3
InChI   1S/C7H6O2.Na/c8-7(9)6-4-2-1-3-5-6;/h1-5H,(H,8,9);/q;+1/p-1
InChI key   WXMKPNITSTVMEF-UHFFFAOYSA-M
storage conditions   Store at +2°C to +25°C.

Description

General description

EMPROVE® ESSENTIAL Ph Eur,BP,NF,FCC,E 211

Application

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

Analysis Note

Assay (acidimetric, calc. on anhydrous substance)99.0 - 100.5 %Assay (HPLC, calc. on anhydrous substance)99.0 - 101.0 %Identitypasses testAppearance of solution (100 g/l, water)passes testAcidity or alkalinitypasses testChloride (Cl)≤ 0.02 %Sulfate (SO₄)≤ 0.01 %Total chlorine≤ 0.03 %Heavy metals (as Pb)≤ 10 ppmAs (Arsenic)≤ 1 ppmCd (Cadmium)≤ 10 ppmCu (Copper)≤ 10 ppmHg (Mercury)≤ 1 ppmPb (Lead)≤ 2 ppmZn (Zinc)≤ 10 ppmBenzene≤ 2 ppmToluene≤ 890 ppmOther residual solvents (ICH Q3C)excluded by production processMultinuclear acidspasses testOxidizable matterpasses testWater (according to Karl Fischer)≤ 1.5 %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,BP,NF,FCC,E 211

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