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Active Pharmaceuticals

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Product Name : Pregablin
Synonym: Pregablin;3-(Aminomethyl)-5-methyl-hexanoic acid
CAS:148553-50-8
MF: C8H17NO2
MW:159.23
Assay: 99.5%
Appearance: White Crystal Powder
Usage: New antiepileptic drugs. Used in the treatment of peripheral neuropathy, or partial seizures adjuvant treatment.

Pregabalin is an anticonvulsant drug used for neuropathic pain and as an adjunct therapy for partial seizures with or without secondary generalization in adults.It has also been found effective for generalized anxiety disorder and is (as of 2007) approved for this use in the European Union.It was designed as a more potent successor to gabapentin. Recent studies have shown that pregabalin is effective at treating chronic pain in disorders such as fibromyalgiaand spinal cord injury. In June 2007, pregabalin became the first medication approved by the U.S. Food and Drug Administration specifically for the treatment of fibromyalgia.

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.

Pregabalin, is a new type of GABA receptor agonists, can block the voltage dependence calcium channel to reduce the neurotransmitter release, mainly used for clinical treatment of peripheral neuropathy and auxiliary for the treatment of localized part seizures.

Items Specification Results
Appearance White or almost white powder White powder
Solubility Practically insoluble in water, freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride conform
Identification IR,UV Positive
Special optical rotation (dried substance) 78.0 to +84.0 81.0°
Impurities A, B and C Impurity A: ≤0.15% 0.01%
Specified impurities: ≤0.10% conform
relative substance Unspecified impurities: ≤0.10% 0.09%
Total impurity: ≤0.3% 0.17%
Loss on drying ≤0.5% 0.20%
Sulfated ash ≤0.1% 0.06%
Assay (on dried basis) 97.5%~102% 99.57%

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