TEST

SPECIFICATION

1.   Solubility

Freely soluble in water, slightly soluble in alcohol 96%v/v.

1. Description

White to yellowish powder.

1. Identification

Complies test EP Ed 6.8.

1. Appearance of the Solution

Complies test EP Ed 6.8.

1. pH

Between 2.4 and 3.0 (EP Ed 6.8)

1. Related substances

Impurity B: NMT 0.15%

Unknown individual impurities: NMT 0.10%

Total impurities: NMT 0.2%

1. Loss on drying:

1. Residue on ignition:

NMT 0.5 % (EP Ed 6.8).

NMT 0.1 % (EP Ed 6.8).

1. Heavy Metals:

Max. 20 ppm (EP Ed 6.8).

1. Particle size:

Pass mesh 1400 µm: NLT 95%.                                                      Pass mesh 150 µm: NLT 35%.

1.  Assay (HPLC):

Between 96.0% and 99.0 %  on dried basis (EP Ed 6.8).