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8.17054 SAFC

Sodium gluconate

USP,E 576

Synonym: Sodium gluconate

  • CAS Number 527-07-1

  • Empirical Formula (Hill Notation) C6H11NaO7

  • Molecular Weight 218.14

  •  MDL number MFCD00064210

  •  E Number E576

  •  EC Index Number 208-407-7

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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   USP
Quality Level   400
form   crystalline powder
autoignition temp.   >200 °C
potency   >2000 mg/kg LD50, oral (Rat)
pH   7.0-8.0 (20 °C, 100 g/L in H2O)
mp   170-175 °C
solubility   590 g/L
InChI   1S/C6H12O7.Na/c7-1-2(8)3(9)4(10)5(11)6(12)13;/h2-5,7-11H,1H2,(H,12,13);/q;+1/p-1
InChI key   UPMFZISCCZSDND-UHFFFAOYSA-M
storage conditions   Store at +5°C to +30°C.

Description

Analysis Note

Assay (perchloric acid titration): 99.0 - 102.0 %
Identity (IR-spectrum): conforms
Identity (Sodium): conforms
Identity (TLC-test): conforms
Appearance: white or almost white, crystalline powder
pH (100 g/l, water): 6.5 - 7.5
Chloride (Cl): ≤ 0.04 %
Sulfate (SO₄): ≤ 0.02 %
Pb (Lead): ≤ 1 ppm
Reducing substances: ≤ 0.5 %
Residual solvents (ICH Q3C): excluded by manufacturing process
Loss on Drying (105 °C): ≤ 0.5 %
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 USP, E 576
Conforms to the purity criteria on food additives according to the current European Commission Regulation.
Corresponds to USP, E 576
Conforms to the purity criteria on food additives according to the current European Commission Regulation.

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