Pregabalin (Pregabalin Drug)

Pregabalin



Pregabalin
(Pregabalin Drug)

Pregabalin (Pregabalin Drug)
Pregabalin (Pregabalin Drug)

Pregabalin is a compound that is chemically and structurally similar to gabapentin, with antiepileptic, analgesic, and anxiolytic properties. Pregabalin has been studied for use in a variety of disorders, including as add-on and monotherapy in refractory partial seizures, diabetic neuropathy, surgical dental pain and other pain syndromes, postherpetic neuralgia, and social anxiety disorders. Pregabalin is a structural analogue of gamma-aminobutyric acid (GABA) and has anxiolytic, analgesic, and antiepileptic properties. Pregabalin is structurally related to gabapentin. The exact mechanism of action of pregabalin as an antiseizure agent has not been determined. Pregabalin does not show direct GABA-mimetic effects, but increases neuronal GABA levels as well as produces a dose-dependent increase in glutamic acid decarboxylase activity.

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 The pregablin drug offerd by us do not contain mandelic acid, which is present in other forms of this drug. It is a common anticonvulsant and helps in the treatment of neuropathic pain, as an adjunct therapy for partial seizures, anxiety disorder.It slows the impulses of brain that is a major cause of seizures. It is also effective in chronic pain, spinal cord injury and fibromyalgia disorder. Pregabalin is a white to off - white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6.

  • TECHNICAL NAME: S-3-(aninomethyl)-5-methylhexanoic acid
  • MOLECULAR FORMULA: C8H17NO2
  • MOLECULAR WEIGHT: 159.23
  • THEORITICAL CATAGORY: Anticonvulsant /Antiepeleptic
  • CAS NO: 148553-50-8
  • SPECIFICATION: In-house
  • H.S.CODE: 30049082
  • WATER CONTENT BY KF: (S) - NMT 2.0% w/w (R) - 0.15%
  • RESIDUE ON IGNITION: (S) - NMT 0.20% w/w (R)-0.08%
  •  SPEICIFIC OPTICAL ROTATION (C=1% w/v in water):(S) - Between 9.0º to 13.0º (on anhydrous basis) (R) - 10.50º
  • HEAVY METALS: (S) - NMT 20 ppm (R) - Complies
  •  RELATED SUBSTANCES: Single Max Imp: (S) - NMT 1.0% (R) - 0.28% Total Impurities: (S) - NMT 2.0% (R) - 0.35%
     
  •  ASSAY BY TITREMETRY (on anhydrous basis): (S) - NLT 98.0% & NMT 102% (R) - 99.75%


Pregabalin is produced by Sienna Biotec and considered to be medium-high volume Active Pharmaceutical Ingredient.

       
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