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Methyl Paraben U.S.P

SPECIFICATION FOR METHYL PARABEN USP/NF
Chemical Name Methyl 4-Hydroxybenzoate (Methyl Paraben) Methyl Paraben I.P Manufacturer
 Molecular Formula C8H8O3
 Molecular Weight 152.15
 CAS Number 99-76-3
 Packing 25 Kg, 20kg (4 x 5 kg)
 The Shelf-life 5 years
 Storage conditions  and  precautions Preserve in a well-closed containers.
 
NO.
Test
Observation
1.
 Description White crystalline powder or colorless crystals.
2.
 Solubility Slightly soluble in water, freely soluble in alcohol and in methanol
3.
 Identification

A. Infrared absorption <197M>.

B. Melting Range <741>:between 125°C and 128°C

4.
 Color of solution The solution is clear and not more intensely colored than matching fluid G.
5.
 Acidity Not more than 0.1 ml of 0.1 N sodium hydroxide is required to produce a blue color.
6.
 Residue on  Ignition Not more than 0.1%.Determine on 1.0 gm.
7.
Related Substances The intensity of any individual secondary spot in the chromatogram of the test solution is not greater than that of the principal spot obtained in the chromatogram of standard solution A (0.5 %).
8.

 Residual Solvents
• Methanol

Method IV <467>. Meets the requirements.
Not more than 3000 ppm

9.
 Assay, w/w Not less than 98.0% and not more than 102.0% of C8H8O3
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