Appearance

White or almost white  powder

Complies

Identification

By IR &HPLC

Complies

Crystallinity

Crystalline

Complies

Solubility

Sparingly  soluble in water,

Complies

pH(0.5 % solution in water)

4.0-5.5

4.6-5.1

Water(Karl Fischer)

4.0-8.0%w/w

5.5-6.5%

Sulphated Ash

NMT 0.2%w/w

0.06-0.11%

Specific Optical Rotation

(0.5% solution in Phthalate buffer solution pH 4.4)

149-158°

151-155°

N,N- Dimethyl Aniline

Not Tested

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Assay Anhydrous Basis(HPLC %)

NLT 98.0% or 980 µg/mg

98.5 – 99.5%

Any Individual Impurity                

NMT 1.0%

0.1-0.5%

Total Impurities                              

NMT 2.0%

0.80-1.2%