Description

Torsemide Impurity 19 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of the active pharmaceutical ingredient (API) Torsemide, a potent loop diuretic. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories to ensure drug purity, safety, and regulatory compliance. The availability of well-characterized impurities like this is essential for method validation and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Torsemide-related substances in drug substances and products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical component in developing and validating chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure Torsemide API meets pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to establish drug shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research on Degradation Pathways: Aids in understanding the chemical behavior and degradation mechanisms of Torsemide.

Basic Information

Product Name	Torsemide Impurity 19
CAS No.	5602-90-4
Molecular Formula	C16H20N4O3S
Molecular Weight	348.42 g/mol
Synonyms	1-[4-[(3-Methylphenyl)amino]pyridin-3-yl]sulfonyl-3-propanoylurea; Torsemide Related Compound; Torsemide Degradant; Torsemide Process Impurity; 1-[4-[(3-Methylphenyl)amino]-3-pyridinyl]sulfonyl-3-(1-oxopropyl)urea; UNII-7J3Q8Q1Z0K; Torsemide Impurity B (EP); Torsemide Impurity F (USP)
EINECS	Contact for details

Quality Control

Our Torsemide Impurity 19 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical analysis. Each batch is subjected to comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of residual solvents and moisture. A Certificate of Analysis (COA) is provided with each shipment, detailing all test results and confirming compliance with in-house specifications aligned with ICH guidelines. We support regulatory needs with full traceability and documentation.

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); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture. For long-term storage, consider storing under an inert atmosphere.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
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.