Pirbuterol Acetate is a pharmaceutical active ingredient belonging to the class of selective β2-adrenergic receptor agonists. It is the acetate salt of pirbuterol and is associated with bronchodilator activity through stimulation of β-adrenergic receptors, which promotes relaxation of bronchial smooth muscle.
Pirbuterol Acetate has the CAS Number 65652-44-0, molecular formula C14H24N2O5, and molecular weight 300.35 g/mol. The substance is registered in the FDA Global Substance Registration System (GSRS) under UNII 1EH73XKR9N.
Pirbuterol Acetate is a well-characterized small-molecule pharmaceutical substance used in respiratory drug-development applications. As an acetate salt, its chemical identity differs from that of the pirbuterol free base, making accurate identification of the salt form important for pharmaceutical manufacturing, analytical testing, documentation, and regulatory compliance.
The API is associated with bronchodilator pharmaceutical applications and may be used in research and development involving respiratory formulations. Its established molecular structure and physicochemical characteristics also make it suitable for analytical method development and quality-control studies.
Pirbuterol Acetate is represented by the molecular formula C14H24N2O5 and has a molecular weight of 300.35 g/mol. The substance is reported as a crystalline solid and is associated with the racemic form of pirbuterol. FDA documentation describes pirbuterol acetate as a white crystalline powder that is freely soluble in water.
The acetate salt contains pirbuterol as the active moiety together with acetic acid/acetate. This distinction is important when specifying the API because pirbuterol free base and pirbuterol acetate have different molecular weights and CAS Registry Numbers.
Pirbuterol Acetate is primarily associated with respiratory pharmaceutical development because of its β-adrenergic bronchodilator activity. It can be relevant to:
Pirbuterol Acetate is also available as an analytical standard for chromatographic applications, including HPLC and GC-related analytical work.
Quality evaluation of Pirbuterol Acetate can involve a range of analytical techniques to confirm identity, purity, and chemical characteristics. Typical analytical approaches include HPLC, NMR, mass spectrometry, and chromatographic analysis of related substances.
For pharmaceutical API applications, analytical testing should be performed according to the applicable approved specification, validated analytical methods, and relevant regulatory requirements. Batch-specific quality should be confirmed through appropriate documentation such as a Certificate of Analysis (CoA).
As a Pirbuterol Acetate API Manufacturer in India, pharmaceutical manufacturers can support research, development, analytical, and commercial API requirements according to applicable quality and regulatory standards.
Pirbuterol Acetate API can be offered with appropriate technical documentation and batch-specific analytical information to support pharmaceutical development and quality-control requirements.
Key product information includes:
Pirbuterol Acetate should be handled and stored in suitable, tightly closed pharmaceutical packaging under conditions that protect the material from excessive moisture, heat, and other unsuitable environmental conditions.
Storage conditions, packaging configuration, retest period, and shelf life should be established according to the applicable product specification and stability data.
Depending on the intended pharmaceutical application, documentation for Pirbuterol Acetate API may include:
Pirbuterol Acetate offers a clearly defined chemical identity and established pharmacological relevance as a β2-adrenergic bronchodilator. Its defined CAS Number 65652-44-0, molecular formula C14H24N2O5, and molecular weight 300.35 g/mol provide important reference points for pharmaceutical procurement, analytical characterization, formulation development, and quality-control activities.
For pharmaceutical applications, Pirbuterol Acetate should always be specified by its correct salt form, CAS number, analytical specification, and applicable regulatory requirements to ensure consistency throughout manufacturing and quality-control processes.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 0.5% |
| Melting Point | >152°C, decomposition |