Butylated Hydroxyanisole USP-NF/Ph.Eur PARENTEX 500GM Go Back

CASR

: 25013-16-5

Molecular Formula

: C11H16O2

Molecular Weight

: 180.25
Specifications  
Appearance/Description: White or yellowish / slightly yellow or slightly pinkish waxy solid or crystalline powder, having a faint, characteristic odor.
Solubility: Freely soluble in alcohol, in propylene glycol, in chloroform and in ether, and in fatty oils. Practically insoluble in water. very soluble in methylene chloride. It dissolves in dilute solutions of alkali hydroxides.
Identification (By IR): All peak positions determined for butylated hydroxyanisole are within 5cm-1 of those determined for 3-tert-Butyl-4-hydroxyanisole standard.
Identification (By Chromatography): The retention time of the main peak of the sample solution corresponds to that of the standard solution. The chromatographic profile of the sample solution similar to that of the standard solution and exhibit only 1 major peak corresponding to BHA.
Identification (By TLC): The principal spot in the chromatogram obtained with test solution (b) is similar in position, color and size to the principal spot in the chromatogram obtained with reference solution (a).
Identification (By chemical test 1): After separation, the organic layer is red.
Identification (By chemical test 2): A red color develops.
Assay(HPLC): NLT 98.5%
Appearance of Solution: Solution is clear and not more intensely colored than intensity 5 of the range of reference solutions of the most appropriate color.
Related substances By TLC (3-(1,1-Dimethylethyl)-4-methoxyphenol): NMT 10.0%
Related substances By TLC (Hydroquinone): NMT 0.2%
Related substances By TLC (Any other impurity): NMT 0.5%
Residue on ignition /Sulfated ash: NMT 0.01%
Total aerobic microbial count: NMT 100CFU/gm
Total Yeast and mold count: NMT 100CFU/gm
Escherichia coli: Should be absent/gm
Bacterial endotoxins: NMT 2.5 EU/gm
Residual solvent as n-Hexane: NMT 200ppm
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