Description

Torsemide Related Compound 1 is a high-purity chemical reference standard, essential for analytical and quality control processes in pharmaceutical development. This compound is critical for ensuring the accuracy and reliability of impurity profiling and method validation for the active pharmaceutical ingredient Torsemide. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, quality assurance, and compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Torsemide drug substance and finished products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or GC analytical methods.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor batch-to-batch consistency and ensure drug purity meets pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products in Torsemide formulations 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 and Development: Facilitates metabolic studies and pharmacokinetic research related to Torsemide.

Basic Information

Product Name	Torsemide Related Compound 1
CAS No.	947327-54-0
Molecular Formula	C16H20N4O3S
Molecular Weight	348.42 g/mol
Synonyms	1-[4-[(3-Methylphenyl)amino]pyridin-3-yl]sulfonyl-3-propan-2-ylurea; Torsemide Impurity 1; Torsemide Related Substance 1; Torsemide EP Impurity A; Torsemide USP Related Compound 1; Demethyl Torsemide; N-Desmethyl Torsemide; UNII-8JQ5607IO5
EINECS	Contact for details

Quality Control

Every batch of Torsemide Related Compound 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced techniques like HPLC and GC to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

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 must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches 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%

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