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