APIs & intermediatesIn evaluation

Salbutamol sulfate

Salbutamoli sulfas · Albuterol sulfate (USP)

CAS51022-70-9Formula(C13H21NO3)2·H2SO4

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.

Technical data

CAS number
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)

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 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.

Quick answers

What is the CAS number of Salbutamol sulfate?

The CAS number of Salbutamol sulfate is 51022-70-9. Molecular formula: (C13H21NO3)2·H2SO4, molar mass 576.7 g/mol.

Which documents come with Salbutamol sulfate 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 Salbutamol sulfate is available?

Ph. Eur. / USP; micronised grades for inhalation on request. Reference standards: Ph. Eur., USP (albuterol sulfate).

Verification

Identifiers checked against public databases on :

Need Salbutamol sulfate?

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

Or write to hello@gfclinics.pl