Ethyl Paraben USP

Test Specification…USP
Appearance It occurs as small, colorless crystals or white powder.
Identification

Test A

Test B

 

a.       Infrared absorption spectrophotometry

b.       Melting point – Between 115 °C to 118 °C

 Solubility Freely soluble in acetone, in alcohol, in ether, and in propylene glycol; slightly soluble in water and in glycerin.
Color of Solution The Sample solution is clear and not more intensely colored than alcohol or the Comparison solution.
Acidity Not More than 0.1 mL is required to produce a blue color.
Related substances

p-Hydroxybenzoic acid

Unspecified impurity

Total impurity

 

Not more than 0.5%

Not more than 0.5%

Not more than 1.0%

Residue on Ignition Not more than 0.1%
Residual Solvents Meets the requirements.
Assay Not less than 98.0% and not more than 102.0% of C9H10O3

Shelf life, Storage and Packing

It should be stored in a segregated area in a cool and ventilated place away from combustible materials. Keep in a tightly closed container, sealed until ready for use. It is packed in 25kg or 50kg HDPE bags or drums as required.

 

Other
GLP, cGMP (FDA) Approved, ISO 9001, ISO 14001, ISO 45001, ISO 17025, ISO 22000, FSSC 22000, FSSAI, Halal and Kosher certified.
We observe WHO Good manufacturing practice and Good laboratory practice.

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