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8.17023 SAFC

Butylhydroxyanisole

E 320

Synonym: BHA, 3-tert-Butyl-4-hydroxyanisole, Butylhydroxyanisole

  • CAS Number 121-00-6

  • Linear Formula 2-[(CH3)3C]-4-(CH3O)C6H3OH

  • Molecular Weight 180.24

  •  MDL number MFCD00040484

  •  E Number E320

  •  EC Index Number 246-563-8

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Antioxidants, Biopharmaceutical Process Development and Manufacturing, Excipients, Liquid Dosage Forms,
Quality Level   400
vapor pressure   1.33 hPa ( 105 °C)
form   crystalline powder
potency   880 mg/kg LD50, oral (Rat)
pH   4.8 (25 °C, 10 g/L in H2O)
bp   263 °C/1013 hPa
mp   48-63 °C
transition temp   flash point 142.1 °C
InChI   1S/C11H16O2/c1-11(2,3)9-7-8(13-4)5-6-10(9)12/h5-7,12H,1-4H3
InChI key   MRBKEAMVRSLQPH-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 (HPLC, butylated hydroxyanisole): ≥ 98.5 %
Assay (HPLC, 2-tert-butyl-4-methoxyphenol): ≥ 90.0 %
Assay (HPLC, 3-tert-butyl-4-methoxyphenol): ≤ 10.0 %
Identity (TLC): passes test
Identity (coloring 1): passes test
Identity (coloring 2): passes test
Identity (HPLC): passes test
Identity (IR-spectrum): passes test
Appearance: White, yellowish or slightly pinkish crystalline powder.
Appearance of solution (100 g/l, ethanol 96 %): Clear and not more intensely colored than intensity 5 of the range of reference solutions of the most appropriate coloracc. to Ph. Eur.
Melting range: 48 - 63 °C
Absorption maximum λ 1 (Ethanol): 289 - 292 nm
Absorption maximum λ 2 (Ethanol): 227 - 230 nm
Spec. Absorptivity A 1%/1cm(λ1max; 0.02 g/l; ethanol): 190 - 210
Spec. Absorptivity A 1%/1cm(λ2max; 0.02 g/l; ethanol): 326 - 345
Heavy metals (as Pb): ≤ 10 ppm
As (Arsenic): ≤ 3 ppm
Hg (Mercury): ≤ 1 ppm
Pb (Lead): ≤ 2 ppm
Related substances (TLC) (3-tert-Butyl-4-methoxyphenol): ≤ 10 %
Related substances (TLC) (Hydroquinone): ≤ 0.2 %
Related substances (TLC) (any other impurity): ≤ 0.5 %
Residual solvents (ICH Q3C): excluded by manufacturing process
Sulfated ash (600 °C): ≤ 0.01 %
Meets analytical specifications of Ph Eur,NF.
The information provided does not imply the suitability of the product for any particular application. It is customer’s sole responsibility, prior to use, to determine that the product is suitable and permitted for the customer’s intended use and application.
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 the purity criteria on food additives according to current European Commission Regulation.

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

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