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1.00193 SAFC

Caprylic acid (Octanoic acid)

EMPROVE® EXPERT Ph Eur,NF

Synonym: Caprylic acid (Octanoic acid)

  • CAS Number 124-07-2

  • Linear Formula CH3(CH2)6COOH

  • Molecular Weight 144.21

  •  MDL number MFCD00004429

  •  EC Index Number 204-677-5

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Properties

Related Categories Biopharmaceutical Manufacturing, Biopharmaceutical Process Development and Manufacturing, Process Chemicals for Biopharmaceutical Manufacturing More...
Agency/Method   NF
  Ph. Eur.
Quality Level   500
vapor pressure   0.05 hPa ( 20 °C)
product line   Emprove® Expert
autoignition temp.   >300 °C
potency   >2000 mg/kg LD50, oral (Rat)
  >5000 mg/kg LD50, skin (Rabbit)
expl. lim.   1 % (v/v)
pH   4 (20 °C, 0.2 g/L in H2O)
bp   237 °C/1013 hPa
mp   16 °C
transition temp   flash point 130 °C
solubility   0.68 g/L
density   0.91 g/cm3 at 20 °C
InChI   1S/C8H16O2/c1-2-3-4-5-6-7-8(9)10/h2-7H2,1H3,(H,9,10)
InChI key   WWZKQHOCKIZLMA-UHFFFAOYSA-N
storage conditions   Store at +15°C to +25°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 (alkalimetric, calculated on anhydrous substance): 99.0 - 100.5 %
Purity (GC): ≥ 99.5 %
Assay (NF): ≥ 99.0 %
Identity (IR-spectrum): passes test
Identity (Density): passes test
Identity (GC): passes test
Appearance: clear, colorless to slightly yellowish liquid, not more intense in color than reference solution Y₅
Density (d 20/20): 0.909 - 0.912
Related substances (GC) (largest single impurity): ≤ 0.3 %
Related substances (GC) (Sum of all impurities): ≤ 0.5 %
Residual solvents (Ph Eur/ICH): excluded by manufacturing process
Sulfated ash (600 °C): ≤ 0.05 %
Water (according to Karl Fischer): ≤ 0.3 %
Peroxide value: ≤ 10.0
Endotoxins: ≤ 1 I.U./ml

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., NF

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