Xipamide is a synthetic sulfonamide diuretic and antihypertensive active pharmaceutical ingredient (API). It belongs to the sulfonamide class of diuretics and is used primarily in pharmaceutical formulations intended to support the management of hypertension and fluid retention. Xipamide is chemically distinct from classical thiazide diuretics, although it shares several pharmacological characteristics with the broader sulfonamide diuretic group.
Xipamide is identified chemically as 4-chloro-N-(2,6-dimethylphenyl)-2-hydroxy-5-sulfamoylbenzamide. The compound has the molecular formula C15H15ClN2O4S and a molecular weight of approximately 354.81 g/mol. Its CAS Registry Number is 14293-44-8, and its UNII is 4S9EY0NUEC.
Xipamide contains a substituted benzamide structure incorporating chloro, hydroxy and sulfamoyl functional groups together with a 2,6-dimethylphenyl substituent. These structural characteristics contribute to its physicochemical and pharmacological properties.
The systematic chemical name of Xipamide is 4-chloro-N-(2,6-dimethylphenyl)-2-hydroxy-5-sulfamoylbenzamide. Other names associated with the compound include BE-1293, BEI-1293 and MJF-10938. It has also been associated with pharmaceutical product names such as Diurexan and Diurex in different markets.
Xipamide is a small-molecule API and is generally handled as a conventional synthetic pharmaceutical compound. It is not a peptide, protein or biological API.
Xipamide is classified pharmacologically as a sulfonamide diuretic. The compound has diuretic and saluretic activity and has been used as an antihypertensive medicine. IUPHAR/BPS identifies Xipamide as an approved drug and classifies it as a sulfonamide diuretic.
Xipamide is classified under ATC code C03BA10, within the cardiovascular-system group of diuretics and the sulfonamides, plain subgroup.
Its pharmacological action is associated with increased renal excretion of sodium and water. This diuretic effect can contribute to reduction of fluid volume and blood pressure, depending on the therapeutic application and dosage regimen.
Xipamide is primarily associated with pharmaceutical products for the treatment of hypertension and conditions involving fluid retention. It has been used in oral dosage forms, particularly tablets.
The API is relevant to pharmaceutical development programs involving cardiovascular and antihypertensive medicines. Its established pharmaceutical history and classification make Xipamide an important ingredient for manufacturers developing or supplying sulfonamide diuretic products.
Xipamide is commercially associated with several regional pharmaceutical products, including Diurexan and other products containing Xipamide as the active ingredient. Brand availability varies between countries and markets.
Xipamide is a synthetic crystalline organic compound with molecular formula C15H15ClN2O4S and molecular weight 354.81 g/mol. The Merck Index and Japanese chemical databases provide the same molecular formula and identify Xipamide as a defined chemical substance.
Available chemical-reference data report a melting point in the approximate range of 253–261°C, although values can vary depending on analytical method, sample history and material characteristics. One commercial analytical reference reports 253–254°C, while a sample COA reports 259–261°C. Therefore, a single melting point should not automatically be treated as a universal release specification.
Xipamide has relatively low aqueous solubility and is reported to be soluble in organic solvents such as methanol and DMSO. Commercial analytical information reports DMSO solubility of approximately 20 mg/mL.
Quality control of Xipamide API requires appropriate identification, assay and impurity testing. HPLC is commonly applicable for assay and chromatographic purity determination. Other analytical techniques such as FTIR, mass spectrometry and NMR may be used for identity confirmation during development and quality assessment.
Commercial analytical material is available with ≥98% HPLC assay, providing a useful reference for high-purity research material. However, this value should not automatically be presented as a universal pharmacopoeial acceptance criterion for commercial API batches. The applicable release specification should be established according to the customer's quality agreement, applicable pharmacopoeia and regulatory requirements.
Related substances and process-related impurities should be appropriately controlled. Residual solvents, elemental impurities, water content and other applicable quality attributes should also be evaluated according to the established API specification.
Xipamide exhibits limited water solubility, which is relevant when developing pharmaceutical formulations. Available references indicate that Xipamide is soluble in methanol and DMSO.
Because solubility can vary according to temperature, solvent composition, particle characteristics and experimental conditions, a single numerical aqueous-solubility value should not be used as a universal specification without a defined analytical method.
The physicochemical properties of Xipamide should therefore be considered during formulation development, particularly when designing oral solid dosage forms.
Xipamide API is relevant to pharmaceutical manufacturers, formulation developers and organizations involved in cardiovascular and antihypertensive product development. A suitable API supply program should provide appropriate analytical documentation, batch-specific quality information and compliance with the required pharmaceutical standards.
Xipamide should be supplied with appropriate identification, assay, impurity, residual-solvent and elemental-impurity controls according to the agreed specification. Depending on the intended market, customers may require a specific pharmacopoeial or regulatory grade.
Xipamide should be stored under controlled conditions appropriate for the specific API batch and packaging system. The material should be protected from excessive moisture, heat and unsuitable environmental exposure.
Good pharmaceutical storage practices should be followed to maintain the chemical and physical quality of the API throughout its shelf life.
Xipamide is an established sulfonamide diuretic API with applications in antihypertensive and cardiovascular pharmaceutical products. Its defined chemical structure, established pharmacological classification and use in oral pharmaceutical formulations make it relevant to pharmaceutical manufacturing and API development.
With the molecular formula C15H15ClN2O4S, molecular weight 354.81 g/mol, and CAS 14293-44-8, Xipamide can be identified and characterized using appropriate pharmaceutical analytical methods.
For API manufacturing and supply, appropriate control of identity, assay, related substances, residual solvents, elemental impurities, water content and other applicable quality attributes is important for maintaining consistent pharmaceutical quality.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | ≥98.0% HPLC |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Water Content | NMT 0.5% |
| Melting Point | Approx. 253–261°C |