APIs & intermediatesCore range

Levetiracetam

Levetiracetamum · (2S)-2-(2-oxopyrrolidin-1-yl)butanamide

CAS102767-28-2FormulaC8H14N2O2

Levetiracetam is an antiepileptic active substance, a pyrrolidone derivative supplied as the single (S)-enantiomer. Among our core APIs it has the highest share of valid CEPs held by Indian manufacturers.

Technical data

CAS number
102767-28-2
Molecular formula
C8H14N2O2
Molar mass
170.21 g/mol
Pharmacopoeia / standards
Ph. Eur. 2535 · USP
Grade
Ph. Eur. / USP, pharmaceutical grade
Appearance
White or almost white powder
Typical packaging
25 kg fibre drums with double polyethylene liners (pack sizes per manufacturer)

Documents we provide

  • CEP or ASMF (applicant’s part) with letter of access
  • EU GMP certificate or inspection record (EudraGMDP)
  • Written Confirmation (CDSCO)
  • Specification and batch CoA
  • Nitrosamine risk assessment
  • Enantiomeric purity data
  • Elemental impurities (ICH Q3D) and residual solvents (ICH Q3C) statements
  • TSE/BSE statement

Typical package. The final list depends on the manufacturer and your specification.

Applications

Active substance for oral and parenteral medicinal products made by authorised manufacturers.

Regulatory notes

Active substance under Directive 2001/83/EC. Imports from India require a Written Confirmation (Art. 46b). Supplied only to authorised manufacturers and wholesalers.

Market context

Indian manufacturers hold 26 of 37 valid CEPs for levetiracetam (EDQM database, 15 Oct 2026; GFC count).

Quick answers

What is the CAS number of Levetiracetam?

The CAS number of Levetiracetam is 102767-28-2. Molecular formula: C8H14N2O2, molar mass 170.21 g/mol.

Which documents come with Levetiracetam from Green Future Clinics?

The typical package includes: CEP or ASMF (applicant’s part) with letter of access; EU GMP certificate or inspection record (EudraGMDP); Written Confirmation (CDSCO); Specification and batch CoA. The final list depends on the manufacturer and on your specification.

Which grade of Levetiracetam is available?

Ph. Eur. / USP, pharmaceutical grade. Reference standards: Ph. Eur. 2535, USP.

Verification

Identifiers checked against public databases on :

Need Levetiracetam?

Send grade, volume and the documents you need. We reply with availability and documentation status.

Or write to hello@gfclinics.pl