Appearance

White or almost 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 0.5 M HCl (w/v)

NMT reference suspension II

%T at 650 nm

96-98.5%

Abs at 430nm 0.035 - 0.070

Clarity of solution NH3
10% sol. in dil. NH3 solution (w/v)

NMT reference suspension II

Complies

Water (Karl Fischer, w/w)

11.5 - 14.5%

13.4 - 13.6%

Sulphated Ash,w/w

NMT 1.0%

0.09 - 0.14%

Specific Optical Rotation

(0.2% solution in water)

290°-315°

298° - 305°

N,N- Dimethyl Aniline

Not Tested

 -

Heavy Metals

NMT 20 ppm

Complies

Assay Anhydrous Basis(HPLC %)

NLT 98% or NLT 980 μg/mg

98.6 -99 .2%

Any Individual Impurity                

NMT 1.0%

0.2 - 0.6%

Total Impurities                              

NMT 2.0%

1.1 - 1.5 %

RESIDUAL SOLVENTS

Isopropyl alcohol

NMT 2000 ppm

250 - 400 ppm

Methanol

NMT 2000 ppm

200 - 300 ppm