Description

Tiotropium Bromide Impurity D CAS NO 736108-96-6 is a high-purity reference standard and a specified impurity of 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 reference materials 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 Tiotropium Bromide Impurity D in drug substances and products.
• Analytical Method Development & Validation: A critical component in developing and validating HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic route optimization and impurity fate and tolerance studies during API process development.

Basic Information

Product Name	Tiotropium Bromide Impurity D
CAS No.	736108-96-6
Molecular Formula	C19H22NO4S2+ • Br-
Molecular Weight	472.42 g/mol
Synonyms	(1R,2R,4S,5S,7s)-9,9-Dihydroxy-9,9-bis(oxidanylidene)-7-[(2-thienylacetyl)oxy]-3-oxa-9λ5-thia-7-azoniatricyclo[3.3.1.12,4]decane Bromide; Tiotropium Bromide Related Compound D; Tiotropium Impurity D; 3-[(Hydroxydi-2-thienylacetyl)oxy]-8,8-dimethyl-8-azoniabicyclo[3.2.1]octane Bromide; 736108-96-6; UNII-8V8K9F8F8F
EINECS	Contact for details

Quality Control

Our Tiotropium Bromide Impurity D is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, residual solvent analysis, and identity confirmation (IR, MS) to ensure it meets the high standards required for pharmaceutical reference materials. Comprehensive Certificates of Analysis (COA) with detailed chromatograms are provided, supporting compliance with ICH guidelines and regulatory requirements.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
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.