Practolol API is a cardioselective beta-adrenergic receptor antagonist belonging to the beta-blocker class. Practolol is chemically identified as N-[4-[2-hydroxy-3-(propan-2-ylamino)propoxy]phenyl]acetamide, with the molecular formula C14H22N2O3 and molecular weight 266.34 g/mol. Its CAS Registry Number is 6673-35-4.
Practolol has historical pharmaceutical importance as a selective β1-adrenergic antagonist and was used particularly in the management of cardiac arrhythmias. However, long-term clinical use became restricted because of serious delayed adverse reactions associated with the oculomucocutaneous syndrome.
Practolol is a synthetic beta-adrenergic blocking agent with selective activity toward β1 receptors. The API is supplied as a solid chemical substance and is commonly characterized by chromatographic, spectroscopic and physicochemical testing.
Chemical identity:
Practolol has one undefined stereocenter in its molecular structure, and the commonly referenced material is racemic/RS practolol.
Practolol is an acetanilide-derived aryloxypropanolamine beta blocker. PubChem reports an XLogP3 value of approximately 0.8, hydrogen-bond donor count of 3, hydrogen-bond acceptor count of 4, and topological polar surface area of 70.6 Ų.
The free base has a reported melting range of 134–136°C. Published physical-property data report solubility of approximately 0.49 g/L, although solubility is dependent on the test conditions and solvent system.
Commercial analytical material from Sigma-Aldrich is described as a white to beige powder and has a stated purity of ≥95% by HPLC. Its listed solubility is 15 mg/mL in DMSO, with storage at 2–8°C. This is a commercial analytical specification rather than a universal pharmacopoeial API release specification.
Historically, Practolol was used as a cardioselective beta-blocker for cardiovascular applications, including the management of cardiac arrhythmias. PubChem identifies emergency treatment of cardiac arrhythmias as a historical drug indication.
Practolol was subsequently withdrawn from widespread clinical use because prolonged exposure was associated with serious oculomucocutaneous reactions, including keratoconjunctivitis sicca, conjunctival scarring and fibrosis, as well as other systemic complications.
The United Nations pharmaceutical regulatory-action database records that Practolol was prohibited for manufacture and sale in India in 1983 because of health risks and/or questionable therapeutic value.
Accordingly, Practolol API should be treated as a historical/regulated pharmaceutical substance, rather than marketed as a routinely used contemporary therapeutic API.
Practolol API quality evaluation can include identity confirmation by HPLC, IR, NMR and/or mass spectrometry, together with chromatographic purity and physicochemical characterization.
For research or analytical material, a commercial specification of ≥95% HPLC is publicly documented. However, this should not be represented as a current universal pharmacopoeial API assay requirement.
Typical analytical controls may include:
Practolol API manufacturing requires controlled synthesis, purification and analytical verification appropriate for the exact free-base material. Identity, chromatographic purity, residual solvents and physicochemical characteristics should be established using validated analytical procedures.
Because Practolol has a history of withdrawal and regulatory restriction, any manufacture, distribution or intended pharmaceutical use should be evaluated against the applicable national regulatory requirements and the intended application.
Practolol is reported as a solid/powder material. Commercial analytical material is listed as white to beige powder and stored at 2–8°C.
Recommended handling should include:
Typical Practolol API documentation may include:
Practolol is a well-characterized historical beta-adrenergic antagonist with established chemical identity and documented analytical properties. The free base has a defined CAS number, molecular formula, molecular weight and established physicochemical profile supported by chemical databases and analytical references.
For analytical, research or appropriately regulated applications, Practolol API can be characterized using validated chromatographic and spectroscopic techniques with supporting batch documentation.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 95.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |