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Tolterodine Tartrate
CAS No.: 124937-52-6
Synonym: Detrol, Detrol LA
Mol. Formula: C₂₂H₃₁NO · C₄H₆O₆
Mol. Weight: 475.57 g/mol
ATC Code: G04BD07
Therapeutic Category: Anticholinergics
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality
Tolterodine Tartrate API is manufactured with a strong emphasis on purity, efficacy, and chemical consistency. Every batch undergoes strict GMP-governed production to ensure high assay values, minimal impurities, and optimal stability. Advanced analytical testing, including HPLC, residual solvent analysis, and impurity profiling, ensures compliance with international pharmacopeial standards. This guarantees a reliable, high-quality API suitable for producing safe and effective formulations for urinary incontinence and overactive bladder therapies.

2) Comprehensive Documentation
A complete regulatory documentation package is provided to support global market submissions. This includes DMF, COA, stability studies, process validation data, MSDS, impurity profiles, and analytical method validation. Documentation is precise, transparent, and structured according to regulatory expectations for both regulated and semi-regulated markets, enabling smooth product registration and formulation development.

3) Secure Supply Chain
The supply chain for Tolterodine Tartrate API is designed for dependability and quality preservation. All raw materials come from qualified suppliers, and each production step is monitored under controlled environments. Secure packaging, validated storage conditions, and robust logistics networks ensure product integrity throughout transportation. This ensures timely deliveries and consistent quality for global clients.

4) Manufacturer & Supplier Expertise
Tolterodine Tartrate API is produced by a highly skilled team of chemists and quality specialists with expertise in complex chemical synthesis and large-scale production. Their experience ensures batch uniformity, process efficiency, and adherence to strict international guidelines. Advanced manufacturing infrastructure further supports reliable, scalable API production.

5) Amber Lifesciences’ Role
Amber Lifesciences supplies high-quality Tolterodine Tartrate API with complete regulatory support, dependable supply, and expert technical assistance. Their commitment to quality, compliance, and reliable CMO/API solutions helps pharmaceutical partners achieve smooth formulation and commercialization processes.

Active Pharmaceutical Ingredient (API) – Not for Direct Human or Veterinary Use.