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1.37020 SAFC

Sodium hydroxide

pellets suitable for the biopharmaceutical production EMPROVE® bio Ph Eur,BP,JP,NF

Synonym: ‘Caustic soda’

  • CAS Number 1310-73-2

  • Linear Formula NaOH

  • Molecular Weight 40.00

  •  MDL number MFCD00003548

  •  EC Index Number 215-185-5

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Excipients, Liquid Dosage Forms, pH Adjusters & Buffers More...
Agency/Method   BP
  JP
  NF
  Ph Eur
Quality Level   500
vapor density   >1 (vs air)
vapor pressure   <18 mmHg ( 20 °C)
  3 mmHg ( 37 °C)
product line   Emprove® API
assay   ≥98.0-100.5% (total alkilinity calculated as NaOH)
form   pellets
pH   >14 (20 °C, 100 g/L in H2O)
mp   318 °C (lit.)
solubility   water: 1090 g/L at 20 °C
density   2.13 g/cm3 at 20 °C
anion traces   carbonate (as Na2CO3): ≤0.5%
  chloride (Cl-): ≤0.015%
  phosphate (PO43-): ≤0.001%
  silicate (as SiO2): ≤0.01%
  sulfate (SO42-): ≤0.010%
cation traces   Al: ≤0.001%
  As: ≤0.0003%
  Ca: ≤0.005%
  Cu: ≤0.0005%
  Fe: ≤0.0010%
  Hg: ≤0.00001%
  K: ≤0.05%
  Mg: ≤0.002%
  Ni: ≤0.001%
  Pb: ≤0.00005%
  Zn: ≤0.0025%
  heavy metals (as Ag): ≤0.002%
  heavy metals (as Pb): ≤0.0005%
SMILES string   [OH-].[Na+]
InChI   1S/Na.H2O/h;1H2/q+1;/p-1
InChI key   HEMHJVSKTPXQMS-UHFFFAOYSA-M
storage conditions   Store at +5°C to +30°C.

Description

Analysis Note

Assay (acidimetric,NaOH): ≥ 98.0 %
Assay (total alkalinity calc. as NaOH): 98.0 - 100.5 %
Assay (Na): 54.0 - 59.8 %
Identity: passes test
Appearance of solution: passes test
Insoluble substances and organic matter: passes test
Carbonate (as Na₂CO₃): ≤ 0.5 %
Chloride (Cl): ≤ 0.015 %
Phosphat (PO4): ≤ 0.001 %
Silicate (SiO₂): ≤ 0.01 %
Sulfate (SO₄): ≤ 0.010 %
Total nitrogen (N): ≤ 0.0005 %
Heavy metals (as Ag): ≤ 0.002 %
Heavy metals (as Pb): ≤ 0.0005 %
Al (Aluminium): ≤ 0.001 %
As (Arsenic): ≤ 0.0003 %
Ca (Calcium): ≤ 0.005 %
Cu (Copper): ≤ 0.0005 %
Fe (Iron): ≤ 0.0010 %
Hg (Mercury): ≤ 0.00001 %
K (Potassium): ≤ 0.05 %
Mg (Magnesium): ≤ 0.002 %
Ni (Nickel): ≤ 0.001 %
Pb (Lead): ≤ 0.00005 %
Zn (Zinc): ≤ 0.0025 %
Residual solvents(Ph Eur/USP/ICH): excluded by manufacturing process
Endotoxins: ≤ 2.5 I.U./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 (*).
conforms to Ph Eur, BP, JP, NF

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

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