test items

enterprise specification

test results

appearance

white to light yellow crystal or crystalline

powder, no odor

white crystalline powder, no odor

specific rotation

-27°~-34°

-32°

identification

1. into 10mg of the substance to be examined,

add 2ml of water for dissolving and 3ml of

hydroxylamine hydrochloride solution, shake

well, and allow to stand for 3min. add 1ml of

acid ferric ammonium sulfate, shake well, and

then the solution shows red brown.

2. add water to dilute 20mg of the substance

to be examined to 100ml, accurately pipette

5ml, and dilute with water to 50ml, to obtain

solution with concentration of 20ug/ml with

water. the maximum absorption should exist

at 293nm, and the minimum absorption should

exist at 241nm.

3. in the chromatogram of the assay, the retention

time of the major peak in the chromatogram

obtained with the test solution corresponds

to that of the major peak in the chromatogram obtained with reference solution.

4. the infrared spectrum of the substance to be examined corresponds to that of the reference spectrum.

1.conform

2.conform

3.conform

4.conform

acidity (10mg/ml)

4.0~6.0

5.3

clarity of solution (10mg/ml)

no more pronounced than that of reference suspension i

less pronounced than that of reference suspension i

color of solution (10mg/ml)

no more intensely colored than the

reference solution yellow no.2

less intensely colored than the reference solution yellow no.1

related substances

the biggest individual impurity

no more than 0.5%

0.2%

total impurity

no more than 1.0%

0.30%

related substance a and related substance b

total impurity no more than 0.5%

not detected

polymer

no more than 0.2%

0.05%

loss on drying

no more than 0.5%

0.05%

residue on ignition

no more than 0.1%

0.04%

heavy metal

no more than 0.0010%

less than 0.0010%

bacterial endotoxin

no more than 0.5eu/mg

less than 0.5eu/mg

report no.: 0004

batch no.: 1207004

test items

specification

test results

sterility

no growth of micro-organisms should

occur after 14 days of incubation

no growth of micro-organisms occurs after 14 days of incubation

residual solvents

methanol

≤0.3%

not detected

tetrahydrofuran

≤0.072%

not detected

acetonitrile

≤0.041%

not detected

n,n-dimethylformamide

≤0.088%

not detected

ethanol

≤0.5%

0.2%

assay (anhydrous)

containing c15h18n4o4s≥98.0%

(containing c15h18n4o4s) 100.6%

particulate matter

>10μm: no more than 5000/vial

>25μm: no more than 500 /vial

>10μm: 1273/vial

>25μm: 30/vial