Methyl Paraben Chemicals

The chemical name for Methyl Paraben Sodium B.P. is Sodium Methyl 4-Hydroxybenzoate. The molecular formula is C8H7NaO3 with the molecular weight of 174.13 and CAS Number 5026-62-0. The shelf life of the chemical is 3 years and is available in packing of 25 Kg and 20 Kg (4 x 5 kg). It is recommended to store the product in tightly closed containers. It is widely used as an Antimicrobial Preservative

The various specifications of the chemical are:

• Character: A white, crystalline powder, freely soluble in water, sparingly soluble in alcohol, practically insoluble in methylene chloride.
• Identification

• Test A: Dissolve 0.5 g in 50 ml of water R. Immediately adds 5ml of hydrochloric acid R1. Filter and wash the precipitate with water R. Dry under vacuum at 80oC for 2 hours. The precipitate obtained melts (2.2.14) at 125°C to 128°C.
• Test B: Examine the precipitate obtained in identification test A by infrared absorption spectrophotometry (2.2.24) comparing with the spectrum obtained with methyl parahydroxy benzoate CRS.
• Test C: Examine the chromatograms obtained in the test for related substances. 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 (c).
• Test D: To about 10 mg in a test-tube add 1 ml of sodium carbonate solution R, boil for 30s and cool. Add 5 ml of aminopyrazolone solution R and 1 ml of potassium ferricyanide solution R and mix. An orange to red colour develops.
• Test E: To 1 ml of Solution S (see Tests) add 1 ml of water R. The solution gives reaction (a) of sodium (2.3.1)
• Appearance of solution: Dissolve 5 gm in carbon-dioxide free water R prepared from distilled water R and dilute to 50 ml examine immediately after preparation is clear (2.2.1) and not more intensely colored than reference solution BY6 (2.2.2, Method I).
• pH: Between 9.5 to 10.5 (1 gm in 1000 ml carbon-dioxide free water)
• Related substances:
• Impurity A: any spot due to impurity A is not more intense than the spot in the Chromatogram obtained with reference solution (a) (4 %)
• Any other impurity: Any spot, apart from the principal spot and due to 4-hydroxy benzoic acid is not more intense than the spot in the chromatogram obtained with reference solution (b) (0.5 %)
• System suitability: The test is not valid unless the chromatogram obtained with reference solution (d) shows two clearly separated principal spots.
• Chlorides: Not more than 350 ppm.
• Sulphate: Not more than 300 ppm.
• Heavy Metals: Not more than 10 ppm.
• Water: Not more than 5.0%.
• Assay: Not less than 99.0% to not more than 102.0% of sodium 4-(methoxycabonyl) Phenolate, calculated with reference to the anhydrous substance.

The chemical name for Methyl Paraben Sodium U.S.P.. is Sodium Methyl 4-Hydroxybenzoate. The molecular formula is C8H7NaO3 with the molecular weight of 174.13 and CAS Number 5026-62-0. The shelf life of the chemical is 3 years and is available in packing of 25 Kg and 20 Kg (4 x 5 kg). It is recommended to store the product in tightly closed containers. It is widely used as an Antimicrobial Preservative.

The various specifications of the chemical are:

• Description: White, hygroscopic powder
• Solubility: Freely soluble in water; sparingly soluble in alcohol; insoluble in fixed oils
• Identification:
• Test A: Dissolve 0.5 gm in 5 ml of water, acidify with hydrochloric acid; and filter the resulting precipitate. Wash the precipitate with water and, dry it over silica gel for 5.0 hrs: The infrared absorption spectrum of a mineral oil dispersion of it exhibits maxima only at the same wavelengths as that of a similar preparation of usp Methyl Paraben RS.
• Test B: Ignite about 0.3 gm, cool, and dissolve the residue in about 3 ml of 3N hydrochloric acid. A platinum wire dipped in this solution imparts an intense, persistent yellow colour to a non-luminous flame.
• PH: Between 9.5 and 10.5, determined in a 0.1% w/v solution, appendix 8.11
• Water: Not more than 5.0 %
• Chloride: Not more than 0.035 %
• Sulphate: Not more than 0.12 %
• Organic volatile impurities: Method-I <467>. Meets the requirements.
• Assay on dried basis (As C8H7NaO3): Not less than 98.5% and not more than 101.5%

The chemical name for Methyl Paraben Sodium I.P. is Sodium Methyl 4-Hydroxybenzoate. The molecular formula is C8H7NaO3 with the molecular weight of 174.13 and CAS Number 5026-62-0. The shelf life of the chemical is 3 years and is available in packing of 25 Kg and 20 Kg (4 x 5 kg). It is recommended to store the product in tightly closed containers. It is widely used as an Antimicrobial Preservative.

The various specifications of the chemical are:

• Description: White, crystalline powder, odorless or almost odorless; hygroscopic.
• Solubility: Freely soluble in water, sparingly soluble in ethanol (95%); practically insoluble in fixed oils
• Identification:
• Test A: Dissolve 0.5 gm in 5 ml of water and acidify to litmus paper with hydrochloric acid; a white precipitate is produced. Wash the precipitate with water and dry. The infrared absorption spectrum of the precipitate, appendix 5.4 is concordant with the reference spectrum of Methyl Paraben or with the spectrum obtained from Methyl Paraben RS.
• Test B: The precipitate obtained in test A on ignition gives the reactions of sodium salts, appendix 3.1
• PH: Between 9.5 to 10.5, determined in a 0.1% w/v solution, appendix 8.11
• Appearance of solution: 10% solution in water is clear, or not more opalescence than Opalescence standard OS1 prepared by 5.0 ml of Opalescence standard & 95 ml of water
• Chloride: Not more than 330 ppm
• Sulphate: Not more than 0.12 %
• Water: Not more than 5.0 %
• Assay on dried basis (As C8H7NaO3): Between 99.0% to 102.0%

The chemical name for Methyl Paraben B.P. is Methyl 4-Hydroxybenzoate. The molecular formula is C8H8O3 with the molecular weight of 152.14and CAS Number 99-76-3. The shelf life of the chemical is 5 years and is available in packing of 25 Kg and 20 Kg (4 x 5 kg). It is recommended to store the product in tightly closed containers. It is widely used as an Antimicrobial Preservative.

The various specifications of the chemical are:

• Appearance A white, Crystalline powder
• Solubility Very slightly soluble in water, freely soluble in alcohol and in Methanol
• Identification:

• Test A: Melts between 96°and 99°.
• Test B: The infra-red absorption spectrum is concordant with the reference spectrum of Propyl Paraben or with the spectrum obtained from Propyl Paraben CRS
• Test C: Examine the chromatograms obtained in the test for related substances. The principle spot in the chromatogram obtained with test solution (b) is similar in position and size to the principle spot in the chromatogram obtained with reference solution (b)
• Test D: To about 10 mg in a test tube add 1 ml of sodium carbonate solution R, boil for 30 seconds and cool (solution A). To a further 10 mg in a test tube add 1 ml of sodium carbonate solution R, the substance partly dissolves (solution B). Add at the same time to each of solutions A and B 5 ml of aminopyrazolone solution and 1 ml of potassium ferricyanide solution R and mix. Solution B is yellow to orange brown. Solution A is orange to Red, the colour is clearly more intense than any similar colour that may be obtained with solution B.
• Appearance of solution: Dissolve 1.0 gm in alcohol R and dilute to 10 ml with the same solvent is clear and not more intensely coloured than reference solution prepared by mixing 1.5 ml ferric chloride colorimetric solution, 0.8 ml cobaltous chloride colorimetric solution, 0.2 ml cupric sulphate colorimetric solution and 97.5 ml of 1% w/v HCl solution.
• Acidity: To 2 ml of the Solution S and 3 ml of Alcohol R, 5 ml of carbon dioxide-free water R and 0.1 ml of bromocresol green solution R. Not more than 0.1 ml of 0.1M sodium hydroxide is required to change the colour of the indicator to blue.
• Related substances: Any impurity: Any spot in the chromatogram obtained with Test Solution (a) apart from the principal spot is not more intense than the spot in the chromatogram obtained with reference solution (a) (0.5 %).
• System suitability: The test is not valid unless the chromatogram obtained with reference solution (c) shows two clearly separated principal spots.
• Sulphated ash, w/w: Not more than 0.1%
• Assay, w/w: 98.0 - 102.0 %