Description

Tiotropium Bromide Impurity 13 is a high-purity reference standard of a specified impurity associated with the active pharmaceutical ingredient Tiotropium Bromide. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable standards to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Tiotropium Bromide drug substance and finished products.
• Analytical Method Development: Serves as a critical component in developing and validating HPLC, UPLC, and GC methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring adherence to ICH Q3A/B guidelines.
• Regulatory Compliance & Filing: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Used to track the formation of this specific impurity over time under various stress conditions.
• Research & Development (R&D): Facilitates studies on degradation pathways and the chemical behavior of Tiotropium Bromide during synthesis and formulation.

Basic Information

Product Name	Tiotropium Bromide Impurity 13
CAS No.	1459721-06-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tiotropium Related Compound; Tiotropium Bromide Related Substance 13; Tiotropium Impurity 13; (1R,2R,4S,5S,7s)-9,9-Dihydroxy-9-phosphoniabicyclo[3.3.1]nonane Bromide (possible structural analog); Tiotropium Bromide EP Impurity; Tiotropium Bromide USP Impurity; Spiro[8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium] Bromide Derivative
EINECS	Contact for details

Quality Control

Our Tiotropium Bromide Impurity 13 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via NMR and MS, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.