Test items CYTISINE

Specification and standard

Results

Assay

≥98.0%

99.01%

Appearance

Light yellow or white Crystalline powder

complies

odour

odourless

complies

Identity

IR,UV,HPLC & Colour reaction

complies

Solubility

Freely soluble in water, methanol, ethanol,soluble in acetonitrile and

chloroform

complies

Clarity of the solution

Not more intensely opalescent

Than reference suspension II

complies

Color of the solution

Not more intensely coloured

Than reference solutionY1

complies

Melting point

154-157℃

156℃

Chlorides

≤0.02%

0.018%

Sulphated Ash

≤0.20%

0.18%

Heavy metal

≤10ppm

complies

Related substance

-N-methylcytisine≤0.5%

complies

-N-formylcytisine≤0.5%

complies

-Total-impurities≤1.0%

0.78%

Arsenic

≤2ppm

complies

Lead

≤2ppm

complies

PH

8-11

9.3

Loss on drying

≤0.6%

0.46%

Residue on solvents

≤0.5%

complies

Total Plate count

≤1000CFU/G

80CFU/G

Yeast & Mold

≤100CFU/G

10CFU/G

E.Coli

Negative

Negative

Salmonella

Negative

Negative