Pregabalin was originally FDA approved in 2004 as an anti-epileptic drug, also called an anticonvulsant. It works by slowing down impulses in the brain that cause seizures. Pregabalin also affects chemicals in the brain that send pain signals across the nervous system.
Pregabalin CAS 148553-50-8 is used to treat pain caused by fibromyalgia, or nerve pain in people with diabetes (diabetic neuropathy), herpes zoster (post-herpetic neuralgia), or spinal cord injury.
Pregabalin is also used with other medications to treat partial-onset seizures in adults and children aged at least 1 month.
|
Item |
Standard |
Result |
|
Appearance |
White or almost white crystalline powder |
White crystalline powder |
|
Specific rotation |
+9.0~ +11.5° |
+10.79° |
|
PH |
6.0~8.0 |
6.77 |
|
Loss on drying |
≤0.5% |
0.02% |
|
Residue on ignition |
≤0.1% |
0.04% |
|
Heavy metals |
≤0.002% |
<0.002% |
|
Assay (on dried basis) |
≥98.5% |
100.8% |
|
R-pregabalin(HPLC) |
≤0.5% |
0.33% |
|
Related substances |
S-(+)-mandel ≤0.1% |
0.3% |
|
Unspecific individual impurity≤0.4% |
0.08% |
|
|
Total impurities≤1.0% |
0.10% |
|
|
Residual solvents |
isopropylketone≤3000ppm tetrahydrofuran≤720ppm |
585.0ppm ND |
|
Conclusion |
Comply with USP/BP/EP standard |
|
