Swapnroop Drugs & Pharmaceuticals is a pharmaceutical API manufacturer and supplier of Tolazamide API in India, supporting pharmaceutical formulation, generic drug manufacturing, bulk API procurement and export requirements.
Tolazamide is an oral sulfonylurea antidiabetic active pharmaceutical ingredient used to lower blood glucose in patients with Type 2 diabetes mellitus. It stimulates insulin secretion from functioning pancreatic beta cells and belongs to the sulfonylurea class of glucose-lowering medicines.
Tolazamide is identified by CAS Number 1156-19-0, with the molecular formula C₁₄H₂₁N₃O₃S and molecular weight 311.40 g/mol. PubChem identifies it as a sulfonylurea hypoglycemic agent and lists the FDA UNII as 9LT1BRO48Q.
Tolazamide is chemically known as 1-(hexahydro-1H-azepin-1-yl)-3-(p-tolylsulfonyl)urea. It is a white to off-white crystalline powder and is very slightly soluble in water, freely soluble in chloroform, soluble in acetone and slightly soluble in alcohol.
Tolazamide belongs to ATC class A10BB05, within the sulfonylurea group of blood-glucose-lowering medicines.
| Parameter | Details |
|---|---|
| Product Name | Tolazamide |
| CAS Number | 1156-19-0 |
| UNII | 9LT1BRO48Q |
| Molecular Formula | C₁₄H₂₁N₃O₃S |
| Molecular Weight | 311.40 g/mol |
| Chemical Name | 1-(Hexahydro-1H-azepin-1-yl)-3-(p-tolylsulfonyl)urea |
| IUPAC Name | 1-(Azepan-1-yl)-3-(4-methylphenyl)sulfonylurea |
| Drug Class | Sulfonylurea |
| Therapeutic Category | Antidiabetic |
| ATC Code | A10BB05 |
| Physical Form | White to off-white crystalline powder |
| Melting Range | Approximately 161–173°C, with decomposition |
The identity, molecular formula and molecular weight are supported by PubChem and the historical/current USP material.
Tolazamide lowers blood glucose primarily by stimulating insulin release from functioning pancreatic beta cells. Like other sulfonylureas, its glucose-lowering effect depends on residual pancreatic beta-cell function.
Tolazamide has been used as an oral antidiabetic API for the management of Type 2 diabetes mellitus.
Its pharmaceutical applications include:
Historical FDA labeling describes Tolinase tablets containing tolazamide in 100 mg, 250 mg and 500 mg strengths.
Swapnroop Drugs & Pharmaceuticals supplies Tolazamide API for pharmaceutical companies requiring sulfonylurea active pharmaceutical ingredients.
As a Tolazamide API supplier in India, Swapnroop supports bulk procurement, formulation development, generic manufacturing and international pharmaceutical supply, subject to applicable specifications and regulatory requirements.
Tolazamide API can be supplied for:
The USP Tolazamide monograph specifies 97.5–102.5% of Tolazamide on the dried basis. It also specifies loss on drying NMT 0.5%, residue on ignition NMT 0.2%, selenium 0.003%, and heavy metals NMT 0.002%. The USP chromatographic purity requirements specify NMT 0.5% for any individual impurity and NMT 1.5% for total impurities.
These values are useful for CMS reference because they are taken from the USP Tolazamide monograph rather than being invented supplier specifications.
The USP monograph specifies that Tolazamide should be preserved in well-closed containers.
The API should be protected from contamination and stored according to the applicable specification, stability data and customer requirements.
Documentation for Tolazamide API may include:
Tolazamide is a well-characterized sulfonylurea antidiabetic API with established pharmaceutical and pharmacopoeial specifications. Swapnroop Drugs & Pharmaceuticals supports pharmaceutical companies seeking Tolazamide API in India for formulation development, bulk procurement, manufacturing and export requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.5–102.5% on dried basis |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | ≤ 1.5% |
| Melting Point | Approx. 161–173°C, with decomposition |