Swapnroop Drugs & Pharmaceuticals is a pharmaceutical Tolterodine Tartrate API manufacturer and supplier in India, providing pharmaceutical-grade active pharmaceutical ingredients for qualified pharmaceutical manufacturers, formulation companies, research organizations, and bulk procurement requirements.
Tolterodine Tartrate is the tartrate salt of tolterodine, an antimuscarinic agent used in the management of overactive bladder, urinary urgency, urinary frequency, and urge urinary incontinence. Tolterodine acts primarily as a competitive antagonist at muscarinic receptors, with activity at M2 and M3 receptor subtypes.
The API is chemically identified as (R)-2-[3-[bis(1-methylethyl)amino]-1-phenylpropyl]-4-methylphenol (2R,3R)-2,3-dihydroxybutanedioate (1:1) salt. Tolterodine Tartrate has the molecular formula C₂₂H₃₁NO·C₄H₆O₆, commonly written as C₂₆H₃₇NO₇, and a molecular weight of 475.57 g/mol. The CAS number is 124937-52-6.
Tolterodine Tartrate is the pharmaceutical salt form of the active (R)-tolterodine enantiomer. The substance is included in the USP 2025 monograph, which establishes requirements for identification, assay, organic impurities, enantiomeric purity, residue on ignition, and loss on drying.
The USP definition specifies 97.0%–103.0% tolterodine tartrate on an as-is basis. The monograph also specifies NMT 0.5% loss on drying and NMT 0.1% residue on ignition.
Tolterodine Tartrate is used as an antimuscarinic active pharmaceutical ingredient for medicines intended to manage symptoms associated with overactive bladder, including urinary urgency, increased urinary frequency, and urge urinary incontinence.
Tolterodine and its active metabolite 5-hydroxymethyltolterodine exert their therapeutic effects through competitive antagonism of muscarinic receptors in the urinary tract.
Swapnroop supports pharmaceutical companies, formulation manufacturers, and qualified procurement organizations seeking Tolterodine Tartrate API for pharmaceutical manufacturing and development applications.
Supply can be provided according to applicable pharmaceutical specifications and customer requirements, with appropriate quality and technical documentation subject to the applicable commercial arrangement.
Tolterodine Tartrate should be preserved in well-closed containers and stored at room temperature, consistent with the USP monograph.
Bulk packaging should provide suitable protection against contamination and environmental exposure.
Depending on the supply arrangement, documentation may include:
Swapnroop Drugs & Pharmaceuticals provides Tolterodine Tartrate API for qualified pharmaceutical, formulation, research, and bulk procurement requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0%–103.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Individual Impurity | NMT 0.20% |
| Total Impurities | NMT 0.50% |