सोडियम मिथाइलपरबेन

Sr. no.

Characteristic

Test Method

Specification

1

Appearance

Visual

White or almost white hygroscopic crystalline powder

2

Solubility

BP

Freely Soluble in water, sparingly soluble in ethanol (96 per cent), practically insoluble in methylene chloride.

Ref. alphabet

Identification

Test Method

Specification

B

Infrared absorption

BP

Matches with standard

D

Reaction of sodium salt

BP

To comply with the monograph

Sr. no.

Test

Test Method

Specification

1

Appearance of solution

BP

A 10 % w/v solution in carbon dioxide-free water clear and not more intensely coloured than BY 6. (Determined on 5.0 gm)

2

pH

BP

9.5 – 10.5

3

Chloride, ppm

BP

Not more than 350

4

Sulphate, ppm

BP

Not more than 300

5

Heavy metals, ppm

BP

Not more than 10

6

Water, % (determined on 0.5 g)

BP

Not more than 5.0

7

Assay by HPLC (as C10H11NaO3), %

BP

94 – 102 (OAB)

8

Impurity A: Impurities, % (HPLC)

BP

Not more than 4.0

9

Unspecified impurities, % (HPLC)

BP

Not more than 0.5

10

Sum of impurities other than A, % (HPLC)

BP

Not more than 1.0