Hot sale & hot cake high quality Pregabalin powder 148553-50-8 with reasonable price and fast delivery !! CAS NO.148553-50-8

product name

pregabalin

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。