APIs & intermediatesCore range

Omeprazole

Omeprazolum

CAS73590-58-6FormulaC17H19N3O3S

Omeprazole is a proton pump inhibitor active substance from the benzimidazole class. It is acid- and light-sensitive, so packaging, storage and transport conditions are part of our documentation review.

Technical data

CAS number
73590-58-6
Molecular formula
C17H19N3O3S
Molar mass
345.42 g/mol
Pharmacopoeia / standards
Ph. Eur. 0942 · USP
Grade
Ph. Eur. / USP, pharmaceutical grade; pellets on request
Appearance
White or almost white powder; shows polymorphism
Typical packaging
Light- and moisture-protected fibre drums with double PE liners

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
  • 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 gastro-resistant oral 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 17 of 30 valid CEPs for omeprazole (EDQM database, 15 Oct 2026; GFC count).

Quick answers

What is the CAS number of Omeprazole?

The CAS number of Omeprazole is 73590-58-6. Molecular formula: C17H19N3O3S, molar mass 345.42 g/mol.

Which documents come with Omeprazole 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 Omeprazole is available?

Ph. Eur. / USP, pharmaceutical grade; pellets on request. Reference standards: Ph. Eur. 0942, USP.

Verification

Identifiers checked against public databases on :

Need Omeprazole?

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

Or write to hello@gfclinics.pl