Tolterodine SR Pellets are pharmaceutical-grade sustained-release multiparticulate pellets containing Tolterodine Tartrate as the active ingredient. These pellets are designed for incorporation into oral dosage formulations where a sustained-release profile and multiparticulate delivery system are required.
Tolterodine Tartrate has the molecular formula C₂₆H₃₇NO₇, molecular weight 475.6 g/mol, and CAS Number 124937-52-6. PubChem also lists 209747-05-7 as another CAS identifier for Tolterodine Tartrate.
Published Indian pharmaceutical pellet portfolios list Tolterodine SR Pellets at 2% strength, making 2% a commonly documented pellet loading for this product.
Tolterodine SR Pellets – 2%
The 2% strength is documented in Indian commercial pellet product portfolios. The final SDP strength should be aligned with the approved SDP product specification.
Tolterodine SR Pellets can be considered for:
Tolterodine Tartrate is the tartrate salt form of Tolterodine. The finished Tolterodine SR pellet system contains the active ingredient together with formulation components used to achieve the intended pellet characteristics and release profile.
The finished pellet's assay, moisture, impurities, particle-size distribution and release characteristics should be evaluated against the applicable finished-product specification. API specifications should not automatically be transferred to the finished pellet.
Tolterodine SR Pellets can be supplied according to the required strength, quantity, packaging configuration and applicable product specifications. Packaging should provide appropriate protection from moisture and environmental exposure during storage and transportation.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 90.0% – 110.0% |
| Loss on Drying | NMT 5.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 5.0% |