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PROPYL PARABEN IP

  • SPECIFICATION OF PROPYL PARABEN I.P.
    Name of finished product Propyl 4-Hydroxybenzoate
    Molecular Formula C10H12O3
    Molecular Weight 180.20
    Packing 5 kg, 20 kg (4 x 5 kg)
    The Shelf-life 5 years
    Storage conditions and precautions Store in a well-closed container.

     

    NO. Test Observation
    1. Description White crystalline powder; odourless.
    2. Solubility Freely soluble in ethanol (95%), in acetone, in ether and in Methanol; very slightly soluble in water.
    3. Identification A. The light absorption in the range 230 to 360 nm of a 0.0005% w/v in ethanol (95%) exhibits a maximum at about 258 nm, absorbance at about 258 nm, 0.44 to 0.47
    B. To about 10 mg in a test tube add 1 ml of sodium carbonate solution, heat to boiling for 30 seconds and cool (solution A) .To a further 10 mg in a test tube add 1 ml of sodium carbonate solution, the substance partly dissolves (solution B). Add at the same time to each of solutions A and B 5 ml of aminophenazone solution and 1 ml of potassium ferricyanide solution and mix. Solution B is yellow to orange brown. Solution A is orange to Red and the colour is clearly more intense than any similar colour that may be obtained with solution B.
    C. Melts between 96o and 990.
    4. Colour and clarity of solution A 10% w/v solution in ethanol (95%) is clear and not more intensely coloured than reference solution (BYS6) 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.
    5. Acidity Dissolve 1.0 g in sufficient ethanol (95%) to produce 10 ml. To 2 ml of the solution add 3 ml of ethanol (95%), 5 ml of carbon dioxide-free water and 0.1 ml of bromocresol green solution. Not more than 0.1 ml of 0.1M sodium hydroxide is required to change the colour of the solution.
    6. Chloride Not more than 500 ppm.
    7. Sulphate Heat 2 g with 100 ml of water, cool, add sufficient water to restore the original volume and filter. To 10 ml of the filtrate add 0.15 ml of dilute hydrochloric acid and 0.1 ml of barium chloride solution; no turbidity is produced within 10 minutes.
    8. Related substances Not more than 0.5 %.
    9. Sulphated ash Not more than 0.1%
    10. Assay, w/w 99.0 – 101.0%

     

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