TEST

SPECIFICATION

Description

A white to almost white powder

Solubility

Practically insoluble in water freely soluble in methylene chloride, soluble in acetone, slightly soluble in methanol

Identification

1. Melting point (118°C-122°C)

2. IR concurrent with std.spectrum

3. To Comply

4. To Comply

Appearance of solution

The solution is clear not more intensely colored than reference standard

Acidity/Alkalinity

For Acidity and point of Solution should be red

For Alkalinity and point of solution should be pink

Related substance

Single impurity : Not More Than 0.25 % w/w of each

Total impurity : Not More Than 0.5 % w/w

Heavy Metals

Not More Than 20 ppm

Loss on drying

Not More Than 0.5 5 w/w

Sulphated Ash

Not More Than 0.1 % w/w

Assay

99.0 % w/w to 101.0 % w/w

TEST

SPECIFICATION

Appearance

A white to pink colored crystalline powder.

Solubility

Practically insoluble in water, freely soluble in ethanol (96%) very slightly soluble in heptanes.

Identification:

Infrared Absorption spectrophotometry

To match with working/Reference standard.

Related Substance by HPLC

Impurity A

Impurity B

Any individual unspecified impurity

Total Impurities

NMT 0.2%

NMT 0.3%

NMT 0.10%

NMT 0.4%

Heavy Metals

NMT 20ppm

Water Content

NMT 0.5% w/w

Sulphated Ash

NMT 0.2% w/w

Assay by HPLC

(Anhydrous Basis)

NLT 98.0% NMT 102.0% w/w

Residual Solvents by GC HS

Methanol

Di-isopropyl ether

Methyl isobutyl ketone

Toluene

NMT 3000ppm

NMT 10ppm

NMT 5000ppm

NMT 890ppm