USD $8.20-8.80 / Kilogram
USD $8.20-8.80 / Kilogram
USD $4.50-5.00 / Liter
USD $1.00-10.00 / Kilogram
USD $1.00-10.00 / Kilogram
USD $100.00-150.00 / Kilogram
USD $100.00-150.00 / Kilogram
USD $3.00-5.00 / Kilogram
USD $3.00-5.00 / Kilogram
specifications |
results |
||
characters |
appearance |
white or almost white powder |
white powder |
solubility |
freely soluble in water and in methanol , practically insoluble in hexane |
conform |
|
identification |
a. infrared absorption |
ir spectrum of the sample corresponds to that of the ref standard |
conform |
b.hplc |
the retention time of the major peak in the chromatograms corresponds to that in the reference standard |
conform |
|
c. tartrate reaction |
positive for tartrate |
conform |
|
test |
clarity of solution |
clear solution(140mg/10ml water) |
clear solution |
color of solution |
absorbance at 420nm nmt0.03 (1.4%w/v solution in water) |
0.003 |
|
ph |
3.3~3.8 |
3.5 |
|
water |
not more than 4.0% |
2.3% |
|
residue on ignition |
not more than 0.1 |
conform |
|
heavy metals |
not more than 20ppm |
nmt 10ppm |
|
boron |
not more than 50ppm |
conform |
|
fluorides |
not more than 50ppm |
conform |
|
silver |
not more than 5ppm |
conform |
|
related compounds |
impurity a |
not more than 0.3% |
0.04% |
any other impurity |
not more than 0.2% |
0.10% |
|
sum of impurities other than a |
not more than 0.7% |
0.23% |
|
residual organic solvent |
|
not more than 0.005% |
0.003% |
|
not more than 0.01% |
0.004% |
|
|
not more than 0.5% |
0.33% |
|
|
not more than 0.5% |
0.05% |
|
not more than 0.3% |
0.06% |
|
|
not more than 0.029% |
0.008% |
|
|
not more than 0.072% |
0.011% |
|
bacterial endotoxins |
not more than 2eu/mg |
conform |
|
microbiological purity( bactenas and mould) |
not more than 100 cfu/g |
conform |
|
enterobacteriaceae |
not detected |
not detected |
|
pseudomonas aeruginosa |
not detected |
not detected |
|
staphylococcus aureus |
not detected |
not detected |
|
assay |
98.0%~102.0%(on the anhydrous basis) |
99.8% |
|
conclusion |
all standards comply with ep6.0 |
specifications |
results |
||
characters |
appearance |
white or almost white powder |
white powder |
solubility |
freely soluble in water and in methanol , practically insoluble in hexane |
conform |
|
identification |
a. infrared absorption |
ir spectrum of the sample corresponds to that of the ref standard |
conform |
b.hplc |
the retention time of the major peak in the chromatograms corresponds to that in the reference standard |
conform |
|
c. tartrate reaction |
positive for tartrate |
conform |
|
test |
clarity of solution |
clear solution(140mg/10ml water) |
clear solution |
color of solution |
absorbance at 420nm nmt0.03 (1.4%w/v solution in water) |
0.003 |
|
ph |
3.3~3.8 |
3.5 |
|
water |
not more than 4.0% |
2.3% |
|
residue on ignition |
not more than 0.1 |
conform |
|
heavy metals |
not more than 20ppm |
nmt 10ppm |
|
boron |
not more than 50ppm |
conform |
|
fluorides |
not more than 50ppm |
conform |
|
silver |
not more than 5ppm |
conform |
|
related compounds |
impurity a |
not more than 0.3% |
0.04% |
any other impurity |
not more than 0.2% |
0.10% |
|
sum of impurities other than a |
not more than 0.7% |
0.23% |
|
residual organic solvent |
|
not more than 0.005% |
0.003% |
|
not more than 0.01% |
0.004% |
|
|
not more than 0.5% |
0.33% |
|
|
not more than 0.5% |
0.05% |
|
not more than 0.3% |
0.06% |
|
|
not more than 0.029% |
0.008% |
|
|
not more than 0.072% |
0.011% |
|
bacterial endotoxins |
not more than 2eu/mg |
conform |
|
microbiological purity( bactenas and mould) |
not more than 100 cfu/g |
conform |
|
enterobacteriaceae |
not detected |
not detected |
|
pseudomonas aeruginosa |
not detected |
not detected |
|
staphylococcus aureus |
not detected |
not detected |
|
assay |
98.0%~102.0%(on the anhydrous basis) |
99.8% |
|
conclusion |
all standards comply with ep6.0 |