# Quetiapine fumarate

Source: https://gfclinics.pl/ingredients/quetiapine-fumarate/
Last reviewed: 2026-10-17 · Green Future Clinics P.S.A.

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.

Synonyms: Quetiapini fumaras

## Technical data

| Property | Value |
|---|---|
| CAS | 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) |
| Category | API |
| Status | In evaluation |

## Documents provided

- 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

## 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.

## Verification

- https://pubchem.ncbi.nlm.nih.gov/compound/5281025

Quotes and documents: https://gfclinics.pl/contact/?product=quetiapine-fumarate