Quetiapine fumarate
Quetiapini fumaras
CAS111974-72-2Formula(C21H25N3O2S)2·C4H4O4
Quetiapine fumarate is an atypical antipsychotic active substance of the dibenzothiazepine class, supplied as the hemifumarate salt. It is under evaluation with Indian manufacturers that hold EU documentation.
Technical data
- CAS number
- 111974-72-2
- Molecular formula
- (C21H25N3O2S)2·C4H4O4
- Molar mass
- 883.09 g/mol
- Pharmacopoeia / standards
- Ph. Eur. · 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
- 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 immediate- and prolonged-release 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.
Quick answers
What is the CAS number of Quetiapine fumarate?
The CAS number of Quetiapine fumarate is 111974-72-2. Molecular formula: (C21H25N3O2S)2·C4H4O4, molar mass 883.09 g/mol.
Which documents come with Quetiapine fumarate 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 Quetiapine fumarate is available?
Ph. Eur. / USP, pharmaceutical grade. Reference standards: Ph. Eur., USP.
Verification
Identifiers checked against public databases on :