- PRODUCT NAME:Pregabalin
Introduction: Welcome to the world of Pregabalin, a remarkable medication renowned for its effectiveness in treating neuropathic pain and certain neurological conditions. Pregabalin belongs to the class of anticonvulsant drugs and is a valuable tool in the management of various medical conditions. This versatile medication offers relief from neuropathic pain and supports emotional well-being in certain individuals. Let's delve into the benefits and applications of Pregabalin in empowering a pain-free and balanced life.
The Power of Pregabalin: Pregabalin's mechanism of action centers on its binding to calcium channels in the central nervous system, reducing the release of certain neurotransmitters involved in pain transmission. By modulating these neurotransmitters, Pregabalin effectively dampens abnormal nerve signals, providing relief from neuropathic pain and certain types of seizures.
Benefits of Pregabalin:
1:Neuropathic Pain Relief: Pregabalin is particularly valuable in managing neuropathic pain caused by conditions such as diabetic neuropathy, post-herpetic neuralgia, and fibromyalgia.
2:Partial-Onset Seizure Management: Pregabalin is indicated for the adjunctive treatment of partial-onset seizures in adults with epilepsy.
3:Generalized Anxiety Disorder Support: In certain individuals with generalized anxiety disorder, Pregabalin can help alleviate symptoms and promote a sense of calmness and well-being.
4:Fibromyalgia Treatment: Pregabalin is FDA-approved for the treatment of fibromyalgia, providing relief from the widespread musculoskeletal pain and tenderness associated with this condition.
5:Restless Legs Syndrome (RLS) Relief: Pregabalin may be considered for individuals with refractory restless legs syndrome, offering potential relief from the discomfort and urge to move the legs during rest.
|
Tests |
Specifications |
Results |
|
Appearance |
White or almost white powder |
White powder |
|
Identification |
A. IR: similar to Reference Substance |
Complies |
|
B. Examine the chromatograms obtained in the test for enantiomeric purity: the principal peak in the chromatogram obtained with the test solution is similar in retention time to the principal peak in the chromatogram obtained with the reference solution. |
Complies |
|
|
Water |
W0.5% |
0.10% |
|
Sulfated ash |
W0.1% |
0.05% |
|
Related substances |
Impurity A W0.15% |
Not Detected |
|
Unspecified impurities eluting before pregabalin (test A) W0.10% |
Not Detected |
|
|
Unspecified impurities eluting after pregabalin (test B) W0.10% |
Not Detected |
|
|
Total for test A and BW0.5% |
Not Detected |
|
|
Enantiomer |
Impurity B W0.15% |
Not Detected |
|
*Benzene |
W2ppm |
Complies |
|
Residual solvents |
Ethyl acetateW500ppm |
Not Detected |
|
Isopropyl alcoholW5000ppm |
168ppm |
|
|
Tetrahydrofuran W 250ppm |
Not Detected |
|
|
Isopropyl ether^200ppm |
Not Detected |
|
|
Ethanol W1 OOOppm |
Not Detected |
|
|
Assay |
98.0%〜102.0% (anhydrous substance) |
99.9% |
|
Tests |
Specifications |
Results |
|
Appearance |
White or almost white powder |
White powder |
|
Identification |
A. IR: similar to Reference Substance |
Complies |
|
B. Examine the chromatograms obtained in the test for enantiomeric purity: the principal peak in the chromatogram obtained with the test solution is similar in retention time to the principal peak in the chromatogram obtained with the reference solution. |
Complies |
|
|
Water |
W0.5% |
0.08% |
|
Sulfated ash |
W0.1% |
0.07% |
|
Related substances |
Impurity A W0.15% |
Not Detected |
|
Unspecified impurities eluting before pregabalin (test A) W0.10% |
Not Detected |
|
|
Unspecified impurities eluting after pregabalin (test B) W0.10% |
Not Detected |
|
|
Total for test A and BW0.5% |
Not Detected |
|
|
Enantiomer |
Impurity BW0.15% |
Not Detected |
|
*Benzene |
W2ppm |
Complies |
|
Residual solvents |
Ethyl acetate ^500ppm |
Not Detected |
|
Isopropyl alcoholW5000ppm |
171ppm |
|
|
Tetrahydrofuran W 250ppm |
Not Detected |
|
|
Isopropyl etherW200ppm |
Not Detected |
|
|
Ethanol W1 OOOppm |
Not Detected |
|
|
Assay |
98.0%~ 102.0% (anhydrous substance) |
99.7% |