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1.06444 SAFC

Sodium chloride

EMPROVE® API Ph Eur,BP,JP,USP

Synonym: Sodium chloride

  • CAS Number 7647-14-5

  • Empirical Formula (Hill Notation) ClNa

  • Molecular Weight 58.44

  •  EC Index Number 231-598-3

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Acidulents & pH Adjusters, Biopharmaceutical Process Development and Manufacturing, Excipients, Liquid Dosage Forms,
grade   BP
  JP
  Ph Eur
  USP
vapor pressure   1.3 hPa ( 865 °C)
potency   3000 mg/kg LD50, oral (Rat)
  >10000 mg/kg LD50, skin (Rabbit)
pH   4.5-7.0 (20 °C, 100 g/L in H2O)
bp   1461 °C/1013 hPa
mp   801 °C
solubility   358 g/L
density   2.17 g/cm3 at 20 °C
bulk density   1140 kg/m3
storage conditions   Store at +2°C to +25°C.

Description

Analysis Note

Assay (argentometric; calculated on dried substance): 99.5 - 100.5 %
Identity: passes test
Appearance of solution: passes test
Acidity or alkalinity: passes test
Bromide (Br): ≤ 0.005
Ferrocyanides: passes test
Iodide (I): passes test
Nitrite (NO₂) (UV-absorption 354nm; 1cm; 10%; water): ≤ 0.01
Phosphate (PO₄): ≤ 0.0025 %
Sulfate (SO₄): ≤ 0.0200 %
Heavy metals (as Pb): ≤ 0.0003 %
Al (Aluminium): ≤ 0.00002 %
As (Arsenic): ≤ 0.0001 %
Ba (Barium): passes test
Ca (Calcium): ≤ 0.002 %
Fe (Iron): ≤ 0.0002 %
K (Potassium): ≤ 0.01 %
Magnesium and alkaline-earth metals (as Ca): ≤ 0.0100 %
Residual solvents (ICH Q3C): excluded by production process
Loss on drying (105 °C, 2 h): ≤ 0.5 %
Endotoxins (kinetic turbidimetric test): ≤ 2.5 I.U./g
Microbiological purity(Total aerobic microbial count (TAMC)): ≤ 1E+02 CFU/g
Microbiological purity(Total yeast and mould count (TYMC)): ≤ 1E+02 CFU/g
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,JP,USP

Safety & Documentation

Safety Information

WGK Germany 
1
RTECS 
VZ4725000

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