Description

Tiotropium Ep Impurity C is a specified impurity and reference standard used in the analytical profiling and quality control of Tiotropium Bromide, a key active pharmaceutical ingredient (API) in respiratory medications. This compound is critical for ensuring the purity, safety, and regulatory compliance of pharmaceutical products by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of inhalation therapies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Tiotropium Bromide impurities in compliance with pharmacopeial monographs (e.g., EP, USP).
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC or UPLC methods for Tiotropium API and its formulations.
• Quality Control & Batch Release: Employed in routine QC testing to monitor impurity levels during API synthesis, ensuring batches meet stringent ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of degradation products in drug substance and drug product stability programs under various ICH storage conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., CMC sections of NDA, ANDA, MAA) to health authorities like the FDA and EMA.
• Research & Development: Supports process chemistry research to understand and minimize impurity formation during the synthesis and purification of Tiotropium Bromide.

Basic Information

Product Name	Tiotropium Ep Impurity C
CAS No.	136310-95-7
Molecular Formula	C19H22NO4S+
Molecular Weight	360.45 g/mol
Synonyms	1αH,5αH-Tropan-3α-yl (2R)-3-Hydroxy-2-phenylpropionate 8-Methyl-8-azabicyclo[3.2.1]oct-3-yl (2R)-3-Hydroxy-2-phenylpropionate; Tiotropium Bromide Impurity C; Tiotropium Related Compound C; (1R,2R,4S,5S,7s)-9-Methyl-9-azabicyclo[3.3.1]nonan-7-yl (2R)-3-hydroxy-2-phenylpropionate; Tiotropium EP Impurity C
EINECS	Contact for details

Quality Control

Our Tiotropium Ep Impurity C is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the exacting standards required for pharmaceutical reference materials. Certificates of Analysis (COA) are provided, detailing batch-specific results and confirming compliance with relevant pharmacopeial specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

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 impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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