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Pregabalin

Pregabalin
CAS: 148553-50-8
MF:  C8H17NO2
MW: 159.23
EINECS: 200-659-6
Purity : 99%
Appearance:Off-White Solid
Usage: New antiepileptic drugs , Active pharmaceutical ingredients

Antiepileptic drugs
Treatment of neuropathic pain
For the treatment of peripheral neuralgia and adjunctive treatment of localized partial seizures

   CERTIFICATE OF ANALYSIS

Product name
Pregabalin
CAS No.
148553-50-8
Outer Packing
25KG
Production date
2015.6
Shelf life
2018.5
Standard adopted
Enterprise standard
Items of analysis
Specification
Results
Appearance
White or almost white powder
conforms
Identification
IRandHPLC
conforms
Loss on drying
≤0.5%
0.2%
Specific Rotation
+10°~+12°
+10.77°
Residue on ignition
≤0.1%
0.08%
Heavy metals
≤20ppm
conforms
impurity C
≤0.1%
conforms
Any impurity
≤0.1%
0.044%
Total impurity
≤1.0%
0.14%
Assay(HPLC)
98%-101%
99.6%
R-isomer
≤0.15%
0.033%
Bromide cintent(Titrmetry)
≤500ppm
26ppm
Ethanol
≤5000ppm
conforms
Isopropyl alcohol
≤5000ppm
142ppm
Ethyl Acetate
≤5000ppm
conforms
Chloroform
≤60ppm
conforms
Conclusion
Qualified

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