Description

Tiotropium Bromide Impurity I is a specified impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient Tiotropium Bromide. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical formulations by providing a benchmark for impurity identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, quality control, and compliance of respiratory medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Tiotropium Bromide Impurity I in drug substances and products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release Testing: Employed as a system suitability and calibration standard in routine QC testing to ensure impurity levels are within ICH/USP/EP specified limits.
• Stability Studies: Utilized to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Essential for preparing impurity profiles and supporting documentation for regulatory filings (e.g., FDA, EMA).
• Research & Development: Used in synthetic chemistry research to study impurity formation pathways and in analytical research for advanced characterization techniques.

Basic Information

Product Name	Tiotropium Bromide Impurity I
CAS No.	136521-48-7
Molecular Formula	C19H22NO4S2+ • Br-
Molecular Weight	472.42 g/mol
Synonyms	(1R,2R,4S,5S,7s)-9,9-Dihydroxy-9,9-bis(2-thienyl)-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane Bromide; Tiotropium Bromide Related Compound I; Tiotropium Bromide EP Impurity I; Tiotropium Bromide USP Impurity I; Tiotropium Bromide Process Impurity; (8r)-6β,7β-Epoxy-8-ethyl-3α-[(2-thienylacetyl)oxy]-1αh,5αh-tropanium Bromide (alternative); 136521-48-7
EINECS	Contact for details

Quality Control

Our Tiotropium Bromide Impurity I is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) are provided, detailing results from tests such as HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis. We support compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.