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Ethyl Paraben B.P.


SYSTEM MANUAL
ISSUE NO : 01
Document No.
Revision No.
Effective date
Page
QAI/Q/03/42
00
1-July-05
1 of 1
ETHYL PARABEN B.P.
 Chemical Name Ethyl Hydroxy Benzoate
 Molecular Formula C9H10O3
 Molecular Weight 166.2

 Structural Formula

 

 CAS Number 120-47-8
 Reference BP- 2002
 Packing 25 kg, 20 kg(4 x 5kg)
 The Shelf-life 5 years
 Storage conditions
and  precautions
Store in well-closed containers.
 Use Antimicrobial Preservative
 
NO.
Test
Observation
1.
 Characters A white or almost white powder, crystalline powder or colourless crystals, 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 115°C and 118°C.
   
B.

The infrared absorption spectrum is concordant with the reference      spectrum of Ethyl paraben or with the spectrum obtained from Ethyl   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,        heat to boiling for 30 seconds and cool (solution A) to a further 10mg       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 aminopyrazolone solution R and 1 ml of potassium ferricyanide solution R 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.

3.
 Appearance of  solution

A 10% w/v solution in ethanol (95%) 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

Dissolve 1.0 g in sufficient ethanol (95%) to produce 10 ml.  To 2 ml of the solution add 3 ml of alcohol R, 5 ml of carbon dioxide-free water and 0.1 ml of bromocresol green solution R. Not more than 0.1ml of 0.1M sodium hydroxide is required to change the colour of the solution to blue.

5.

 Related  substances

Not more than 0.5 %
6.
 Sulphated ash (w/w) Not more than 0.1 %.
7.
 Assay on anhydrous  basis 98.0 to 102.0 %.
8.
Additional test Loss on Drying (80°C/2h),w/w Not more than 0.5%.
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