USD $5.00-7.00 / Gram
USD $5.00-7.00 / Gram
USD $10.00-100.00 / Kilogram
USD $5.00-7.00 / Gram
USD $5.00-7.00 / Gram
USD $5.00-7.00 / Gram
USD $5.00-7.00 / Gram
USD $5.00-7.00 / Gram
USD $5.00-7.00 / Gram
product name | pregabalin |
cas number | 148553-50-8 |
molecular formula | c8h17no2 |
molecular weight | 159.23 |
appearance | white or near white crystalline powder |
melting point | 194-196ºc |
boiling point | 274ºc at 760 mmhg |
flash point | 119.5ºc |
vapour pressure | 0.00153mmhg at 25°c |
relative density | 0.997 g/cm3 |
product name |
|||
batch no. |
20170305 |
mfg.date |
2017.03.05 |
net weight |
30000kg |
expiry.date |
2019.03.04 |
cas no |
148553-50-8 |
related standards |
usp39 |
test items |
standards |
results |
|
appearance |
white to off-white crystalline powder |
white crystalline powder |
|
solubility |
sparingily soluble in water slightly |
conform |
|
identification color reaction |
ninhydrin reaction solution is blue purple |
conform |
|
identification |
ir |
conform |
|
specific optical rotation |
+8.5°~+12.0°(odb) |
+10.51° |
|
related substance(hplc) |
amide≤0.15% |
bql |
|
4e≤0.15% |
bql |
||
5e≤0.15% |
0.01% |
||
lactum≤0.15% |
bql |
||
unknown impurity≤0.15% |
0.04% |
||
total impurity≤0.50% |
0.05% |
||
heavy metal |
≤20ppm |
<20ppm |
|
sulphate ash |
≤0.1%w/w |
0.049%w/w |
|
loss on drying |
≤0.5%w/w |
0.10%w/w |
|
residual solvent(gc) |
methanol≤3000ppm |
45ppm |
|
toluene≤890ppm |
bql |
||
n-butanol≤5000ppm |
123ppm |
||
ethyl acetate≤5000ppm |
bql |
||
chloroform≤60ppm |
bql |
||
n-hexane≤290ppm |
bql |
||
emantiomeric purity by hplc r-pregabalin content |
not more than 0.15% of the area of r-pregabalin |
bql |
|
assay(hplc) |
98.0%~102.0%(on dried basis) |
99.97% |
|
conclusion :the sample complies with usp39。 |
analytical chemist:wenwenxu qa manager: liangdong