GMP Certificate Zopiclone API

Limited liability company ;GMP Certificate
molecular formula,molecular weight
C
12
H
17
CLN
6
O
3
388.81

Molecular Structure



Test item
official standard
Internal standard
character
white or slight yellow crystal powder,taste slightly bitter.Dissolve under light,almost insoluble in water.easily dissolve in chloroform and dichloroethane,slightly dissolve in methanol, dimethyl formamide, and ethanol.
melting point is 175~178°C. Isorotation is - 0.05°C to +0.05°C

White to almost white or slight yellow crystal powder,taste slightly bitter.Dissolve under light,almost insoluble in water.easily dissolve in chloroform and dichloroethane,slightly dissolve in methanol, dimethyl formamide, and ethanol.
melting point is 175~178°C. Isorotation is - 0.05°C to +0.05°C

identification
(1)
qualified
qualified
(2)
biggest absorption in the 303nm wave length place, the absorption coefficient ((E
1
1c
%
m
)) is 345~380.
biggest absorption in the 303nm wave length place, the absorption coefficient ((E
1
1c
%
m
)) is 345~380.
(3)
infrared light absorption atlas is consistent with the comparison atlas.
infrared light absorption atlas is consistent with the comparison atlas.
inspection
clarification and color
Clarify,colorless
Clarify,colorless
chloride
≤0.010%
≤0.010%
related substance
Impurity total quantity≤0.5%
Impurity total quantity≤0.5%
Loss on drying
≤0.5%
≤0.48%
Residue on ignition
≤0.1%
≤0.1%
Heavy metal
≤20/1,000,000
≤20/1,000,000
assay
Calculated on the anhydrous substance ≥98.5%
Calculated on the anhydrous substance ≥98.8%
category
hypnotic.
storage
Shade and seal preserve
Shelf-life
Two years