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  • 1.06757 - Methyl 4-hydroxybenzoate

1.06757 SAFC

Methyl 4-hydroxybenzoate


Synonym: Methyl 4-hydroxybenzoate, Methylparaben, 4-Hydroxybenzoic acid methyl ester

  • CAS Number 99-76-3

  • Linear Formula 4-(OH)C6H4(COOCH3)

  • Molecular Weight 152.15

  •  MDL number MFCD00002352

  •  EC Index Number 202-785-7



Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Excipients, Liquid Dosage Forms, Preservatives,
Agency/Method   BP
  Ph. Eur.
Quality Level   500
reg. compliance   FCC
vapor pressure   0.000005 hPa ( 20 °C)
product line   EMPROVE® Essential
assay   99.0-100.5% (HPLC)
  99.0-102.0% (acidimetric)
autoignition temp.   >600 °C
potency   2100 mg/kg LD50, oral (Rat)
pH   5.8 (20 °C in H2O, saturated solution)
mp   125 °C
solubility   1.88 g/L
density   1.38 g/cm3 at 20 °C
bulk density   300‑400 kg/m3
InChI   1S/C8H8O3/c1-11-8(10)6-2-4-7(9)5-3-6/h2-5,9H,1H3
storage conditions   Store at +15°C to +25°C.



The specification of the product is part of the Emprove® Material Qualification Dossier and can be found under "General Properties".

Analysis Note

Assay (Acidimetric): 99.0 - 102.0 %
Assay (HPLC): 99.0 - 100.5 %
Identity: passes test
Appearance of solution: passes test
Acidic substances: passes test
Melting range (lower value): ≥ 125 °C
Melting range (upper value): ≤ 128 °C
Heavy metals (as Pb): ≤ 10 ppm
As (Arsenic): ≤ 3 ppm
Cd (Cadmium): ≤ 10 ppm
Cu (Copper): ≤ 10 ppm
Hg (Mercury): ≤ 1 ppm
Pb (Lead): ≤ 2 ppm
Zn (Zinc): ≤ 10 ppm
Related substances (HPLC): passes test
p-Hydroxy benzoic acid: ≤ 0.5 %
Sum of all impurities: ≤ 1.0 %
Largest unspecified impurity: ≤ 0.5 %
Methanol (HS-GC): ≤ 3000 ppm
Other residual solvents (ICH Q3C): excluded by manufactoring process
Sulfated ash: ≤ 0.05 %
Loss on drying (80 °C): ≤ 0.5 %
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, FCC

Legal Information

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

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Safety Information

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