Appearance

White crystalline powder

Complies

Identification

By IR, HPLC & Chemically

Complies

Crystallinity

Crystalline

Complies

Solubility

Slightly  soluble in water,

Complies

pH(0.2% sol. in water, w/v)

4.0-5.0

4.3-4.7

Clarity of solution HCl                     10% sol. In 1.0 M HCl (w/v)

NMT reference suspension II

%T at 650 nm

96-98.5%

Abs at 430nm 0.02-0.045

Clarity of solution NH₃

10% sol. In dil.NH₃solution (w/v)

NMT reference suspension II

Complies

Water(Karl Fischer, w/w)

NMT 12.0-15.0%

13.3-13.6%

Sulphated Ash, w/w

NMT 0.5%

0.08-0.12%

Specific Optical Rotation

0.25% solution in water

280-305°

289°-294°

N,N- Dimethyl Aniline

Not Tested

 -

Heavy Metals

NMT 20 PPM

Complies

Assay Anhydrous Basis(HPLC %)

NLT 98.5% or NLT 985 µg/mg

98.8 – 99.4%

Any Individual Impurity                

NMT 1.0%

0.1-0.5%

Total Impurities                              

NMT 2.0%

0.80-1.3%

RESIDUAL SOLVENTS

Isopropyl Alcohol

NMT 2000 ppm

350-500 ppm

Methanol

NMT 2000 ppm

200-300 ppm