Description

Tiotropium Bromide Impurity CAS NO 1044148-31-3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Tiotropium Bromide, a key medication for chronic obstructive pulmonary disease (COPD). It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in Tiotropium Bromide drug substance and finished products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection.
• Quality Control and Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Used to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Tiotropium Bromide formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and justify specifications.
• Research and Development: Facilitates research into the degradation pathways, synthesis, and chemical behavior of Tiotropium Bromide and related compounds.

Basic Information

Product Name	Tiotropium Bromide Impurity
CAS No.	1044148-31-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(1R,2R,4S,5S,7s)-9-[(2-Hydroxy-2,2-dithien-2-ylacetyl)oxy]-9-methyl-3-oxa-9-azoniatricyclo[3.3.1.0²,⁴]nonane Bromide; Tiotropium Bromide Related Compound; Tiotropium Impurity; Tiotropium Bromide Degradation Product; Tiotropium Bromide Process Impurity; Spiriva Impurity
EINECS	Contact for details

Quality Control

Our Tiotropium Bromide Impurity is manufactured under strict quality systems to ensure the highest standards of purity and traceability. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from advanced analytical techniques. We adhere to relevant ICH Q3A/B guidelines for impurities and can supply material suitable for use in regulatory submissions. Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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