Description

Tiotropium Bromide Impurity 1 is a specified impurity and degradation product of the active pharmaceutical ingredient Tiotropium Bromide, a long-acting muscarinic antagonist used in the management of chronic obstructive pulmonary disease (COPD). This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control to ensure drug safety and efficacy. It is essential for analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical industry working on API synthesis, impurity profiling, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Tiotropium Bromide API and finished drug products.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling and stability-indicating assays.
• Quality Control & Assurance: Employed in routine QC testing of API batches to monitor and control impurity levels per ICH guidelines.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Used to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Tiotropium Bromide to minimize the formation of this specific impurity.

Basic Information

Product Name	Tiotropium Bromide Impurity 1
CAS No.	2109037-83-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tiotropium Related Compound; Tiotropium Bromide Related Substance; Tiotropium Impurity A; Tiotropium Bromide Degradation Product; Spiriva Impurity; (1R,2R,4S,5S,7s)-9-[(2S)-3-[(2-hydroxy-2,2-dithiophen-2-ylacetyl)oxy]-2,2-dimethylpropyl]-9-azoniatricyclo[3.3.1.0²,⁴]nonane Bromide Impurity
EINECS	Contact for details

Quality Control

Every batch of Tiotropium Bromide Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation, purity assessment, and impurity profiling via advanced chromatographic techniques. Certificates of Analysis (COA) containing detailed analytical results are available upon request to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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