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CAS NO.148553-50-8
99%(1-25)Kilogram98%(1-25)Kilogram
1. Pharmacological efficacy: Pregabalin is a novel γ-aminobutyric acid (GABA) receptor agonist, can block the voltage-dependent calcium channels to reduce neurotransmitter release.
2. The main clinical for the treatment of peripheral neuropathic pain as well as part of adjuvant treatment of focal seizures.
3. Treatment of epilepsy in developing the most promising drug in a drug treatment better and more convenient administration. Can also be used to treat pain and anxiety.
|
TEST
|
SPECIFICATION |
Results |
|
Description |
White to off-white crystalline powder.
|
White crystalline powder |
|
Solubility
|
Sparingly soluble in water |
Sparingly soluble in water |
|
Identification By IR
|
The infrared absorption spectrum of the substance being examined should be concordant with the infrared absorption spectrum of Pregabalin reference standard / working standard. |
complies |
|
Specification optical rotation [C=1 % w/v in water at 200C] |
Between+10.0o to + 12.0º; on anhydrous basis. |
+11.6o |
|
Heavy metals |
Not more then 20 ppm |
Complies |
|
Related substances [By HPCL] Single unspecified impurity Total impurity |
Not more than 0.5%
Not More than 1.0 % |
0.23 %
0.31 % |
|
Water content [By KF] |
Not more than 0.5 % w/w
|
0.18 % w/w
|
|
Sulphated ash
|
Not more than 0.1%w/w
|
Complies |
|
Assay [By titration] |
Not less than 98.0 % and not more than 102.0% on anhydrous basis. |
98.7%w/w |
