Butyl Paraben

Parabens are a class of widely used preservatives in cosmetic and pharmaceutical products. Chemically, they are a series of parahydroxybenzoates or esters of parahydroxybenzoic acid (also known as 4-hydroxybenzoic acid). Parabens are effective preservatives in many types of formulas. These compounds, and their salts, are used primarily for their bactericidal and fungicidal properties. They are found in shampoos, commercial moisturizers, shaving gels, personal lubricants, topical/parenteral pharmaceuticals, suntan products, makeup, and toothpaste. They are also used as food additives. Parabens are active against a broad spectrum of microorganisms.

Parabens are esters of para-hydroxybenzoic acid, from which the name is derived. Common parabens include methylparaben (E number E218), ethylparaben (E214), propylparaben (E216), butylparaben and heptylparaben (E209). Less common parabens include isobutylparaben, isopropylparaben, benzylparaben and their sodium salts. All commercially used parabens are synthetically produced, although some are identical to those found in nature. They are produced by the esterification of para-hydroxybenzoic acid with the appropriate alcohol, such as methanol, ethanol, or n-propanol.

Butylparaben, or butyl p-hydroxybenzoate, is an organic compound with the formula C4H9O2CC6H4OH. It is a white solid that is soluble in organic solvents. It has proven to be a highly successful antimicrobial preservative in cosmetics. It is also used in medication suspensions, and as a flavoring additive in food. Members of the paraben family are found in fruit and vegetable products, such as barley, flax seed, and grapes. Butylparaben is one of the most common bactericidal/fungicidal additives in cosmetics. The popularity of butylparaben in these products is due to its low toxicity in humans and its effective antimicrobial properties, in particular those against mold and yeast.

Butylparaben USP NF Grade
C11H14O3 194.23
Benzoic acid, 4-hydroxy-, butyl ester.
Butyl p-hydroxybenzoate [94-26-8].

Butylparaben contains not less than 98.0 percent and not more than 102.0 percent of C11H14O3.

Identification:
A: Infrared Absorption 197M .
B: Melting range: between 68C and 71C.

Color of solution: Dissolve 1 g in alcohol, dilute with alcohol to 10 mL, and mix (Butylparaben solution). This solution is clear and not more intensely colored than alcohol or a solution prepared immediately before use by mixing 2.4 mL of ferric chloride CS, 1.0 mL of cobaltous chloride, and 0.4 mL of cupric sulfate CS with 0.3 N hydrochloric acid to make 10 mL, and diluting 5 mL of this solution with 0.3 N hydrochloric acid to make 100 mL. Make the comparison by viewing the solutions downward in matched color-comparison tubes against a white surface.
Acidity: To 2 mL of Butylparaben solution prepared in the Color of solution test, add 3 mL of alcohol, 5 mL of carbon dioxide-free water, and 0.1 mL of bromocresol green, and titrate with 0.10 N sodium hydroxide: not more than 0.1 mL is required to produce a blue color.
Residue on ignition: not more than 0.1%, determined on 1.0 g.
Related substances: To pass the test
Assay: To about 1.000 g of Butylparaben, accurately weighed, add 20.0 mL of 1 N sodium hydroxide, and heat at about 70C for 1 hour. Cool rapidly in an ice bath. Carry out the titration on the solutions at room temperature. Titrate the excess sodium hydroxide with 1 N sulfuric acid, continuing the titration until the second point of inflection and determining the endpoint. Perform a blank determination. Each mL of 1 N sodium hydroxide is equivalent to 194.2 mg of C11H14O3.

Butyl Hydroxybenzoate BP Grade
Butylparaben
Butyl Parahydroxybenzoate, Ph Eur
C11H14O3 --- 194.2 --- 94-26-8
Action and use: Excipient.

DEFINITION
Butyl 4-hydroxybenzoate.
Content: 98.0 per cent to 102.0 per cent.

CHARACTERS
Appearance: White or almost white, crystalline powder or colourless crystals.
Solubility: Very slightly soluble in water, freely soluble in alcohol and in methanol.

IDENTIFICATION
First identificationı A, B.
Second identificationı A, C, D.
A. Melting point 68C to 71C.
B. Infrared absorption spectrophotometry. Comparisonı butyl parahydroxybenzoate CRS.
C. Examine the chromatograms obtained in the test for related substances.
Results: The principal spot in the chromatogram obtained with test solution (b) is similar in position and size to the principal spot in the chromatogram obtained with reference solution (b).
D. To about 10 mg in a test-tube add 1 ml of sodium carbonate solution, boil for 30 s and cool (solution A). To a further 10 mg in a similar test-tube add 1 ml of sodium carbonate solution; the substance partly dissolves (solution B). Add at the same time to solution A and solution B 5 ml of aminopyrazolone solution and 1 ml of potassium ferricyanide solution and mix. Solution B is yellow to orange-brown. Solution A is orange to red, the colour being clearly more intense than any similar colour which may be obtained with solution B.

TESTS
Solution S: Dissolve 1.0 g in alcohol and dilute to 10 ml with the same solvent.
Appearance of solution: Solution S is clear and not more intensely coloured than reference solution.
Acidity: To 2 ml of solution S add 3 ml of alcohol, 5 ml of carbon dioxide-free water and 0.1 ml of bromocresol green solution. Not more than 0.1 ml of 0.1 M sodium hydroxide is required to change the colour of the indicator to blue.
Related substances: Thin-layer chromatography to pass the test (0.5 per cent).
Sulphated ash: Maximum 0.1 per cent, determined on 1.0 g.

ASSAY
To 1.000 g add 20.0 ml of 1 M sodium hydroxide. Heat at about 70C for 1 h. Cool rapidly in an ice bath. Prepare a blank in the same manner. Carry out the titration on the solutions at room temperature. Titrate the excess sodium hydroxide with 0.5 M sulphuric acid , continuing the titration until the second point of inflexion and determining the end-point potentiometrically. 1 ml of 1 M sodium hydroxide is equivalent to 194.2 mg of C11H14O3.

IMPURITIES
A. R = H: 4-hydroxybenzoic acid,
B. R = CH3: methyl 4-hydroxybenzoate,
C. R = CH2-CH3: ethyl 4-hydroxybenzoate,
D. R = CH2-CH2-CH3: propyl 4-hydroxybenzoate.

Certifications :
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