Synonyms:(3s)-3-(aminomethyl)-5-methylhexanoic acid;Pregabalin;Pregablin;3-(aminomethyl)-5-methyl-hexanoic acid;Prednisolonesodiumphosphate;(r)-pregabalin;(s)-pregabalin
CAS: 148553-50-8
MF: C8H17NO2
MW: 159.23
Chemical Properties: Off-White Solid
Packing:25kg/drum or as required
Pregabalin COA:
Pregabalin COA:
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