Description

Trospium Chloride Related Compound C is a high-purity chemical reference standard, essential for analytical and quality control processes in pharmaceutical development. This compound serves as a critical impurity marker for the active pharmaceutical ingredient Trospium Chloride, ensuring the safety and efficacy of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of related substances in Trospium Chloride API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or GC methods to monitor impurities during manufacturing.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure drug substance and product meet stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to track impurity formation over time.
• Regulatory Compliance & Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate control over the manufacturing process and product purity.
• Research & Development: Utilized in synthetic chemistry R&D for route scouting and process optimization to minimize the formation of this specific impurity.

Basic Information

Product Name	Trospium Chloride Related Compound C
CAS No.	3464-71-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Trospium Chloride Impurity C; Trospium Chloride Related Substance C; Trospium EP Impurity C; Trospium USP Related Compound C; (1R,3r,5S)-3-[(2S)-3-Hydroxy-2-phenylpropanoyl]oxy-8-methyl-8-azabicyclo[3.2.1]octane; 8-Methyl-8-azabicyclo[3.2.1]oct-3-yl (2S)-3-hydroxy-2-phenylpropanoate; Nortropine Tropate
EINECS	Contact for details

Quality Control

Our Trospium Chloride Related Compound 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 high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Handle and store in accordance with good laboratory practices.

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)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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