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1.06303 SAFC

di-Sodium tetraborate decahydrate

EMPROVE® ESSENTIAL Ph Eur,BP,JP,NF

Synonym: Borax, Sodium biborate decahydrate, Sodium borate decahydrate, di-Sodium tetraborate decahydrate

  • CAS Number 1303-96-4

  • Empirical Formula (Hill Notation) B4Na2O7 · 10H2O

  • Molecular Weight 381.37

  •  MDL number MFCD00149193

  •  EC Index Number 215-540-4

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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,
Agency/Method   BP
  JP
  NF
  Ph Eur
Quality Level   500
vapor pressure   0.213 hPa ( 20 °C)
potency   2660 mg/kg LD50, oral (Rat)
  >2000 mg/kg LD50, skin (Rabbit)
pH   9.2 (20 °C, 47 g/L in H2O)
mp   75 °C (Elimination of water of crystallisation)
solubility   49.74 g/L
density   1.72 g/cm3 at 20 °C
bulk density   750 kg/m3
InChI   1S/B4O7.2Na.10H2O/c5-1-9-3(7)11-4(8)10-2-6;;;;;;;;;;;;/h;;;10*1H2/q-2;2*+1;;;;;;;;;;
InChI key   OJPFLODMGUZMKD-UHFFFAOYSA-N
storage conditions   Store at +5°C to +30°C.

Description

Analysis Note

Assay (acidimetric): 99.0 - 103.0 %
Identity: passes test
Appearance of solution: passes test
pH-value (4 %; water): 9.2 - 9.5
pH-value (5 %; water): 9.1 - 9.6
carbonate, bicarbonate: passes test
Sulfate (SO₄): ≤ 0.0050 %
Heavy metals (as Pb): ≤ 0.0020 %
Al (Aluminium): ≤ 0.0001 %
As (Arsenic): ≤ 0.0005 %
Ca (Calcium): ≤ 0.0100 %
Fe (Iron): ≤ 0.0005 %
NH₄ (Ammonium): ≤ 0.0010 %
Residual solvents (ICH Q3C): excluded by 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 (*).

Corresponds to Ph Eur, BP, JP, NF

Safety & Documentation

Safety Information

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