Description

Torasemide Impurity 4 is a designated impurity of the loop diuretic pharmaceutical, Torasemide. This compound is critical for analytical reference and quality control processes in pharmaceutical development and manufacturing. It is primarily used by research institutions, quality assurance laboratories, and API producers to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Torasemide Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods (e.g., HPLC, UPLC) used in stability studies and release testing.
• Quality Control & Assurance (QC/QA): Used as a system suitability standard and for setting impurity acceptance criteria to meet pharmacopeial guidelines (USP, EP, ICH Q3A/B).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity profiles and demonstrating comprehensive control strategies to agencies like the FDA and EMA.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity under various stress conditions to determine drug shelf-life.
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this impurity during API manufacturing.

Basic Information

Product Name	Torasemide Impurity 4
CAS No.	106944-62-1
Molecular Formula	C16H20N4O3S
Molecular Weight	348.42 g/mol
Synonyms	1-Isopropyl-3-[(4-methylphenyl)amino]sulfonyl-4-[(pyridin-3-yl)methyl]amino]pyridine-5-carboxylic acid; Torasemide Related Compound; Torasemide EP Impurity D; Torasemide USP Impurity; 4-[(3-Methylphenyl)amino]pyridine-5-carboxylic acid derivative; 1-Isopropyl-4-[(3-pyridinylmethyl)amino]-3-[(4-methylphenyl)sulfonyl]amino]-1H-pyrazole-5-carboxylic acid (alternative tautomer representation); Torsemide Impurity 4
EINECS	Contact for details

Quality Control

Every batch of Torasemide Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing 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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants.

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 individual 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.