Description

Tiotropium Bromide Impurity 16 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, 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 researchers, analytical chemists, and quality assurance professionals in pharmaceutical companies and contract research organizations (CROs) who require precise impurity profiling and method validation.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity during the development and manufacturing of Tiotropium Bromide API.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to ensure accurate detection and quantification limits.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to confirm that Tiotropium Bromide drug substance and drug product batches meet stringent purity specifications as per ICH guidelines.
• Stability Studies: Used to track the formation and level of this impurity over time under various stress conditions, supporting shelf-life determination and packaging decisions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., to FDA, EMA) to demonstrate comprehensive understanding and control of the API's impurity profile.
• Research and Development: Aids in synthetic route optimization and process chemistry studies by helping to understand the origin and fate of this specific process-related impurity.

Basic Information

Product Name	Tiotropium Bromide Impurity 16
CAS No.	1978292-75-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tiotropium Impurity 16; Tiotropium Bromide Related Compound 16; (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; 3-Oxa-9-azoniatricyclo[3.3.1.0²,⁴]nonane, 9-[(hydroxydi-2-thienylacetyl)oxy]-9-methyl-, bromide, (1R,2R,4S,5S,7s)-; Tiotropium Bromide EP Impurity G; Tiotropium Bromide USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Tiotropium Bromide Impurity 16 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, chromatographic data, and spectroscopic identification (e.g., by HPLC, NMR, MS).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated place. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.