ITEMS	STANDARDS	RESULTS
Appearance	A white to off white powder	White powder
Identification	A. Meets the requirement	Complies
	B. IR: similar to Reference Substance	Complies
Loss on drying	≤0.5%	0.21%
Specific Rotation	+10.0°~+13.0°	+10.8°
Related Substances	Any single impurity ≤0.1% Total impurity ≤0.8%	0.05% 0.10%
Purity By HPLC R-isomer	≤0.15%	0.10
Residue on ignition	≤0.1%	0.05%
Residual solvents	Isopropyl alcohol ≤5000ppm Ethyl Acetate ≤5000ppm	150ppm 250ppm
Heavy metals	≤10ppm	Complies
Chlorides	≤0.05%	Complies
Assay	98%~102.0%	99.8%
Conclusion	Analyse according to Factory Standard , Conform

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CAS	148553-50-8
Name	pregabalin
Appearance	white powder
Molecular Formula	8H17NO2
Molecular Weight	159.226
Density	0.997 g/cm3
PSA	63.32
LOGP	1.7824
Boiling point	274ºC
Melting point	194-196ºC
Flash point	119.5ºC
Refractive index	1.464