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PREGABALIN

Product Identification

Synonyms : (S)-3-(aminoethyl)-5-methylhexanoic acid
Chemical Structure :
Molecular Formula : C8H17NO2
Molecular Weight : 159.23
CAS NO. : [148553-50-8 ]

Specification

Appearance : White to Off-white crystalline powder
Identification by IR :

The IR spectrum of the sample shall be concordant with that of standard spectrum

By HPLC :

The retention time of the sample peak should conform to that of standard in enantiomeric purity method

Enantiometric purity <br>

PRB-IV: (R)-(-)-3-Aminomethyl-

5-methylhexanoic acid (R-Isomer)
: NMT 0.5%
Water content (% w/w) : NMT 0.5%
Residue on ignition (%) : NMT 0.1%
Heavy metals : 20ppm
Assay : NLT  98.0% and NMT 102.0% (on dried basis)          

Transportation

UN No. : Not regulated.
Hazardous Class : Not regulated.
Packing Group : Not regulated.

Packing & Storage

Packing : 20kg in Fibre drums
Storage : Store in a cool, dry place. Store in a tightly closed container

Application

  • Pregabalin, also known as β-isobutyl-γ-aminobutyric acid (beta-isobutyl-GABA), is a medication used to treat 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
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