TEST

SPECIFICATION

RESULT

Description

White or almost white crystalline powder

White crystalline powder

Solubility

Practically insoluble in water, soluble in acetone , sparingly soluble in ethanol (96%), It dissolves in dilute mineral acids.

Complies

Identification

First identification: (C) Infrared absorption spectrophotometry

Complies

Acidity or Alkalinity

Not more than 0.4 ml of 0.01M HCL is require to change the colour of the indicator to red

Complies

Related substance

Impurity A at 265 nm : NMT 0.1% Impurity B at 265 nm : NMT 0.1% Impurity C at 265 nm : NMT 0.5% Impurity D at 265 nm : NMT 0.2% Impurity E at 265 nm : NMT 0.5% Impurity F at 265 nm : NMT 0.3%

Not Detected Not Detected 0.2089% 0.0715% 0.1220% Not Detected 0.0367% 0.4630%

Single Unknown Impurity : NMT 0.10% Total Impurities : NMT 1.0%

Loss on drying

Not More than 0.5% w/w

0.22% w/w

Sulphated Ash

Not More than 0.1% w/w

0.066% w/w

Assay (On dried basis)

NLT 99.00% w/v and NMT 101.00 % of C22H19NO4 on dried basis

99.60% w/w