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1.06386 SAFC

Sodium carbonate monohydrate

EMPROVE® ESSENTIAL Ph Eur,BP,NF,E 500

Synonym: Soda monohydrate, Sodium Carbonate Monohydrate, Sodium carbonate monohydrate

  • CAS Number 5968-11-6

  • Empirical Formula (Hill Notation) CNa2O3 · xH2O

  • Molecular Weight 105.99 (anhydrous basis)

  •  MDL number MFCD00149177

  •  E Number E500

  •  EC Index Number 207-838-8

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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
  NF
  Ph. Eur.
Quality Level   500
product line   Emprove® Essential
potency   4090 mg/kg LD50, oral (Rat)
pH   11-12 (25 °C, 50 g/L in H2O)
mp   854 °C (anhydrous substance)
density   2.25 g/cm3 at 20 °C
bulk density   820 kg/m3
InChI   1S/CH2O3.2Na.H2O/c2-1(3)4;;;/h(H2,2,3,4);;;1H2/q;2*+1;/p-2
InChI key   MQRJBSHKWOFOGF-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 (Na₂CO₃): 83.0 - 87.5 %
Assay (acidimetric; calculated on dried substance): 99.5 - 100.5 %
Identity: passes test
Appearance of solution: passes test
Alkali hydroxides and Alkali hydrogen carbonates: passes test
Chloride (Cl): ≤ 0.0125 %
Sulfate (SO₄): ≤ 0.0250 %
Heavy metals (as Pb): ≤ 0.0010 %
As (Arsenic): ≤ 0.0003 %
Cu (Copper): ≤ 0.0025 %
Fe (Iron): ≤ 0.0050 %
Hg (Mercury): ≤ 0.0001 %
Pb (Lead): ≤ 0.0002 %
Zn (Zinc): ≤ 0.0025 %
Residual solvents (ICH Q3C): excluded by manufacturing process
Loss on drying (300 °C): 12.0 - 15.0 %
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, BP, NF, E 500
Conforms to the purity criteria on food additives according to the current European Commission Regulation.

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

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