Description

Hydrochlorothiazide Related Compound (N'-(2-Acetyl-Sulfamoyl-4-Chloro-Phenyl) Acetamide) is a high-purity chemical reference standard and pharmaceutical intermediate of significant analytical importance. This compound is critical for ensuring the quality, safety, and efficacy of Hydrochlorothiazide, a widely prescribed diuretic medication, by serving as a key marker for impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on compliance and product integrity. The compound is supplied with full analytical documentation to support rigorous pharmacopeial standards.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Hydrochlorothiazide Active Pharmaceutical Ingredients (APIs) and finished dosage forms, per ICH Q3B guidelines.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC) methods for stability-indicating assays.
• Quality Control & Batch Release Testing: Employed in routine QC testing to monitor impurity levels, ensuring batch-to-batch consistency and compliance with stringent pharmacopeial specifications (USP, EP, JP).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and long-term stability programs.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles, specifications, and the overall safety of the drug substance.
• Research & Synthesis: Acts as a chemical intermediate or starting material in organic synthesis for developing novel thiazide derivatives or related pharmaceutical compounds.

Basic Information

Product Name	Hydrochlorothiazide Related Compound (N'-(2-Acetyl-Sulfamoyl-4-Chloro-Phenyl) Acetamide)
CAS No.	90794-87-9
Molecular Formula	C10H11ClN2O4S
Molecular Weight	290.72 g/mol
Synonyms	N'-(2-Acetylsulfamoyl-4-chlorophenyl)acetamide; 4-Chloro-N-(4-chloro-3-sulfamoylphenyl)acetamide derivative; Hydrochlorothiazide Impurity; Hydrochlorothiazide Related Substance; HCTZ Related Compound; 2-Acetylsulfamoyl-4-chloroacetamilide; 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide related compound
EINECS	Contact for details

Quality Control

Every batch of this related compound is manufactured and analyzed under strict quality management systems to ensure it meets the exacting standards required for pharmaceutical analysis. Our rigorous quality testing includes identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and mass spectrometry. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines. We support cGMP requirements for materials intended for use in regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The container should be kept in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
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
Loss on Drying	≤ 0.5%

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