Pregabalin CAS 148553-50-8

FAQ - Technical & Supply Chain

• Q:

  What is Pregabalin CAS 148553-50-8?

  A: Pregabalin is the (S)-enantiomer of 3-(aminomethyl)-5-methylhexanoic acid, with molecular formula C8H17NO2 and molecular weight about 159.23. It is also listed as (3S)-3-(aminomethyl)-5-methylhexanoic acid and is normally supplied as a white to almost white crystalline powder.
• Q:

  Why is enantiomeric purity important for Pregabalin?

  A: Pregabalin is a chiral pharmaceutical raw material, so the undesired enantiomer can affect product identity and acceptance. Pharmacopoeial grade material is typically controlled by chiral HPLC, with the related R-isomer or Pregabalin Related Compound A limited to not more than 0.15%.
• Q:

  What are the main applications of Pregabalin?

  A: Pregabalin is used as a pharmaceutical active ingredient in antiepileptic therapy, peripheral neuropathic pain and adjunctive treatment of partial seizures. For industrial sourcing, the exact grade, target pharmacopoeia and intended regulatory market should be confirmed rather than assuming all Pregabalin grades are interchangeable.
• Q:

  Which pharmacopoeial quality attributes should be confirmed for Pregabalin?

  A: Key attributes include assay at 98.0%-102.0% on the dried basis, loss on drying not more than 0.5%, residue on ignition not more than 0.1%, chloride not more than 0.1%, enantiomeric purity, related substances and residual solvents. The applicable monograph or manufacturer specification may add limits for specific impurities.
• Q:

  How should Pregabalin be stored and what should a sourcing inquiry specify?

  A: Store Pregabalin in tightly closed containers, protected from light, at not more than 25 deg C. A sourcing inquiry should state the target grade, pharmacopoeial or registration requirement, packaging, quantity and destination so the quotation matches the intended controlled-use application.