Items

Standard

Result

Appearance

A yellow crystalline Powder

Conforms

Assay

Between 98.0% and 102%

99.6%

Identification

UV, IR, TLC

Conforms

Particle size

100% pass through 120 mesh sieve

Conforms

Solubility

Soluble in water,slightly soluble in alcohol,insoluble in ether and acetone

Conforms

PH(0.5% w/c solution in water)

Between 6.0 and 7.5

6.50

Specific absorbance (0.003% solution in water at 375 nm)

Between 315 and 345(on dried basis)

319.0

Specific optical rotation (0.5% solution at 23℃ inwater)

-550℃ to -580℃(on dried basis)

-562.69℃

Loss on drying

≤4.0%

2.20%

Moisture content(By KF)

≤3.0%

1.85%

Sulphated Ash

≤0.1%

0.07%

Related substance.

Colchicine

Other impurities

≤0.5%

Not more than 2 number,neither of then is not more intense to 0.5%

Less than 0.5%

Less than 2 and more of impurity is more intense to 0.5%

Potentiial impurities

N-deacetyl N-fomyl Colchicoside: ≤0.5%

Colchicoside ≤0.5%

Colchiceine ≤0.5%

Total unknown impurities ≤0.5%

ND

0.24%

0.33%

0.27%

Residual solvent

Chloroform ≤60ppm

Methanol ≤3000ppm

Ethanol ≤5000ppm

48ppm

1113ppm

1606ppm

Bacterial Endotoxin

87.5EU/mg max

Conforms

Aerobic bacterial count

≤1,000 cfu/g

Conforms

Total Yeast & Mold

≤100 cfu/g

Conforms

Escherichia coli

Negative              

Conforms

Salmonella

Negative

Conforms

Staphylococus aureus

Negative              

Conforms

Pseudomeneas aeruginosa Enterobacteriaceae

Negative

Conforms