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|Molecular Formula:||C8H17NO2||Molecular Weight:||159.23|
|Melting Point:||194-196 Degree Centigrade||Boiling Point:||274 Degree Centigrade At 760 Mmhg|
product name: Pregabalin
Usage: A GABA Analogue Used as an Anticonvulsant
Delivery: Sent out Within 12 Hours After Payment Confirmed
Shipping: Express Courier(EMS, DHL, UPS, TNT, FedEx)
HS Code: 29144000
Product Categories: APIs;Miscellaneous Biochemicals;Intermediates & Fine Chemicals;
2. Product Description:
Enantiomer of Pregabalin. A GABA analogue used as an anticonvulsant. Anxiolytic analgesic
used to treat peripheral neuropathic pain and fibromyalgia.Pregabalin is an anticonvulsant drug used for neuropathic pain, as an adjunct therapy for partial seizures, and in generalized anxiety disorder. It was designed as a more potent successor to gabapentin. Pregabalin is marketed by under the trade nam.
Pregabalin is used to relieve neuropathic pain (pain from damaged nerves) that can occur in your arms,
hands, fingers, legs, feet, or toes if you have diabetes or in the area of your rash if you have had shingles (a painful rash that occurs after infection with herpes zoster). It is also used to treat fibromyalgia
(a long-lasting condition that may cause pain, muscle stiffness and tenderness, tiredness, and difficulty falling
asleep or staying asleep). Pregabalin is used with other medications to treat certain types of seizures in
people with epilepsy. Pregabalin is in a class of medications called anticonvulsants. It works by decreasing the number of pain signals that are sent out by damaged nerves in the body.
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.
LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless
solution contained in a 16 fluid ounce white HDPE bottle with a Polyethylene lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients.
4. Pregabalin COA:
|Appearance||A white to off white powder||White powder|
|Identification||A. Meets the requirement||Complies|
|B. IR: similar to Reference Substance||Complies|
|Loss on drying||≤0.5%||0.21%|
|Related Substances||Any single impurity ≤0.1%
Total impurity ≤0.8%
|Purity By HPLC R-isomer||≤0.15%||0.10|
|Residue on ignition||≤0.1%||0.05%|
|Residual solvents||Isopropyl alcohol ≤5000ppm
Ethyl Acetate ≤5000ppm
|Conclusion||Analyse according to Factory Standard , Conform|