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Product Name: | Pregabalin | Other Name: | (S)-3-Aminomethyl-5-methyl-hexanoic Acid |
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CAS: | 148553-50-8 | Appearence: | White Or Nearly White Crystalline Powder |
Purity: | 99% | MF: | C8H17NO2 |
MW: | 159.226 | WhatsApp: | +86 17683962426 |
High Light: | Pregabalin Pharmaceutical Raw Material,Anti Epileptic Pregabalin powder |
Product Name
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Pregabalin |
Synonym |
3(S)-(AMINOMETHYL)-5-METHYLHEXANOIC ACID;(3S)-3-(AMINOMETHYL)-5-METHYLHEXANOIC ACID;PREGABALIN;Pregablin;3-(Aminomethyl)-5-methyl-hexanoic acid;PREDNISOLONESODIUMPHOSPHATE;(R)-Pregabalin;(S)-Pregabalin
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CAS
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148553-50-8 |
MF
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C8H17NO2 |
MW
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159.23 |
EINECS
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200-659-6 |
Purity
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99.8% |
Appearance
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White Crystal Powder |
Usage |
S-Enantiomer of Pregabalin. A GABA analogue used as an anticonvulsant. Anxiolytic analgesic used to treat peripheral neuropathic pain and fibromyalgia.
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Storage
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Store in cool and dry area and keep away from direct sunlight |
Regabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.
Pregabalin works by reducing the abnormal electrical activity in the brain. It is taken alongside other medicines for epilepsy. Pregabalin can also be helpful in treating the symptoms of generalised anxiety disorder (GAD), particularly if other medicines which are more often prescribed for people with this condition are not suitable. GAD is a long-term condition where anxiety is a major symptom.
Pregabalin, also known as β-isobutyl-γ-Aminobutyric acid (β-isobutyl-GABA) and sold under the trade name Lyrica among others, is a medication used to in the treatment of epilepsy, neuropathic pain, fibromyalgia and generalized anxiety disorder. Its use for epilepsy is as an add-on therapy for partial seizures with or without secondary generalization in adults.
Pregabalin is a structural analogue of the neurotransmitter GABA, consequently it belongs to the γ-Aminobutyric acid analogue class of antiepileptic drugs. Its a ion channel modulator that has analgesic, anticonvulsant, sedative, and anxiolytic properties. Pregabalin is a potent gabapentinoid and close analogue of GABOB (β-hydroxy-GABA), baclofen (β-(4-chlorophenyl)-GABA), and phenibut (β-phenyl-GABA).
Application:
Pregabalin belongs to a group of medicines known as anti-epileptic medicines, although it is prescribed for the treatment of several different conditions. You may have been prescribed it for the treatment of partial seizures, which is a type of epilepsy. A seizure is a short episode of symptoms which is caused by a burst of abnormal electrical activity in the brain. With a partial seizure, the burst of electrical activity stays in one part of the brain. Therefore, you tend to have localised or 'focal' symptoms. Pregabalin is also prescribed to treat certain types of long-lasting pain caused by damage to nerves. This type of pain, called neuropathic pain, can be caused by a number of different conditions, including diabetes (where it is called diabetic neuropathy) and shingles(where it is called postherpetic neuralgia).
Item
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Specification |
Result |
Appearance
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A white to off white powder |
White powder |
Identification
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A. Meets the requirement | Complies |
B. IR: similar to Reference Substance | Complies | |
Loss on drying
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≤0.5% |
0.21% |
Specific Rotation
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+10.0°~+13.0° |
+10.8° |
Related Substances
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Any single impurity ≤0.1% Total impurity ≤0.8% |
0.05% |
Purity By HPLC R-isomer
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≤0.15% |
0.10% |
Residue on ignition
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≤0.1% |
0.05% |
Residual solvents | Isopropyl alcohol ≤5000ppm Ethyl Acetate ≤5000ppm |
150ppm |
Heavy metals
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≤10ppm |
Complies |
Chlorides
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≤0.05% |
Complies |
Assay
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98%~102.0% |
99.8% |
Conclusion
|
Conform |
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