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Methyl Paraben E.P.

SYSTEM MANUAL
ISSUE NO : 01
Document No.
Revision No.
Effective date
Page
QAI/Q/03/14
03
1-Jul-07
1 of 1
METHYL PARABEN BP
 Chemical Name Methyl 4-Hydroxybenzoate>
 Molecular Formula C8H8O3
 Molecular Weight 152.14
 Structural Formula
 Methyl Paraben I.P Manufacturer
 CAS Number 99-76-3
 Packing 25 Kg, 20kg(4 x 5 kg)
 The Shelf-life 5 years
 Storage conditions and  precautions Store in a well-closed containers.
 Use Antimicrobial Preservative
 
NO.
Test
Observation
1.
 Appearance A white, Crystalline powder.

2.

 Solubility Very slightly soluble in water, freely soluble in alcohol and in Methanol.
2.
 Identification

First identification: A, B.

Second identification: A, C, D.

A.   Melts between 125°C and 128°C.

B.   The infrared absorption spectrum is concordant with the reference spectrum of methyl paraben or with the spectrum obtained from methyl paraben CRS.

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).

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

3.
 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.
4.
 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.
5.
 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.

6.
 Sulphated ash Not more than 0.1%
7.
 Assay, w/w

98.0 - 102.0 %

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