# Salbutamol sulfate

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

Salbutamol sulfate is a short-acting beta2-adrenoceptor agonist active substance, supplied as the 2:1 sulfate salt. It is under evaluation with Indian manufacturers that hold EU documentation.

Synonyms: Salbutamoli sulfas; Albuterol sulfate (USP)

## Technical data

| Property | Value |
|---|---|
| CAS | 51022-70-9 |
| Molecular formula | (C13H21NO3)2·H2SO4 |
| Molar mass | 576.70 g/mol |
| Pharmacopoeia / standards | Ph. Eur.; USP (albuterol sulfate) |
| Grade | Ph. Eur. / USP; micronised grades for inhalation on request |
| 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 inhaled, 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.

## Verification

- https://pubchem.ncbi.nlm.nih.gov/compound/9884233

Quotes and documents: https://gfclinics.pl/contact/?product=salbutamol-sulfate