Description

Torsemide Impurity T-1C is a high-purity reference standard of a specified process-related impurity. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and regulatory affairs teams to ensure the purity, safety, and efficacy of the active pharmaceutical ingredient, Torsemide.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Torsemide Impurity T-1C in drug substances and finished products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating stability-indicating methods to monitor impurity profiles during stability studies and forced degradation.
• Quality Control & Batch Release: Serves as a system suitability standard in routine QC testing to comply with ICH Q3A(R2) and Q3B(R2) guidelines on impurities in new drug substances and products.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities.
• Stability Studies: Employed to track the formation and level of this specific impurity over the shelf-life of the drug product under various storage conditions.
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this impurity during the manufacturing of Torsemide.

Basic Information

Product Name	Torsemide Impurity T-1C
CAS No.	164595-81-7
Molecular Formula	C16H20N4O3S
Molecular Weight	348.42 g/mol
Synonyms	1-Isopropyl-3-[(4-m-toluidino-3-pyridyl)sulfonyl]urea; Torsemide Related Compound T-1C; Torsemide Impurity C; Torsemide USP Related Compound C; Demethyl Torsemide; 1-Isopropyl-3-{[4-(3-methylphenyl)amino]-3-pyridinyl}sulfonylurea
EINECS	Contact for details

Quality Control

Every batch of Torsemide Impurity T-1C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The product is light-sensitive and should be handled under appropriate conditions 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)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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