# Losartan potassium

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

Losartan potassium is an angiotensin II receptor antagonist (sartan) active substance supplied as the potassium salt. Because sartans are subject to specific nitrosamine controls in the EU, the documentation package includes a nitrosamine risk assessment and test data.

Synonyms: Losartanum kalicum; Losartan K

## Technical data

| Property | Value |
|---|---|
| CAS | 124750-99-8 |
| Molecular formula | C22H22ClKN6O |
| Molar mass | 461.00 g/mol |
| Pharmacopoeia / standards | Ph. Eur. 2232; USP |
| Grade | Ph. Eur. / USP, pharmaceutical grade |
| Appearance | White or almost white, hygroscopic crystalline powder; shows polymorphism |
| Typical packaging | 25 kg fibre drums with double polyethylene liners (pack sizes per manufacturer) |
| Category | API |
| Status | Core range |

## 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 oral medicinal products made by authorised manufacturers, alone or in fixed combinations.

## Regulatory notes

Active substance under Directive 2001/83/EC. Sartans follow the EMA nitrosamine requirements introduced after the 2019 Article 31 review. Supplied only to authorised manufacturers and wholesalers.

## Market context

Indian manufacturers hold 18 of 30 valid CEPs for losartan potassium (EDQM database, 15 Oct 2026; GFC count).

## Verification

- https://pubchem.ncbi.nlm.nih.gov/compound/11751549

Quotes and documents: https://gfclinics.pl/contact/?product=losartan-potassium