Description

Hydrochlorothiazide Related Compound (n-[(2-Aminophenyl)Sulfonyl] Acetamide) is a high-purity chemical reference standard and a key intermediate in pharmaceutical synthesis. This compound is critical for quality control and research & development within the pharmaceutical industry, ensuring the purity and safety of active pharmaceutical ingredients (APIs). It is primarily utilized by analytical laboratories, research institutions, and manufacturers involved in the production and validation of diuretic drugs, specifically for the analysis of Hydrochlorothiazide and related substances.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Hydrochlorothiazide API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and other chromatographic methods in compliance with ICH guidelines.
• Pharmaceutical Research: Serves as a crucial intermediate or starting material in the synthesis and structural elucidation of thiazide diuretics and their derivatives.
• Quality Assurance/Quality Control (QA/QC): Employed in routine batch testing to monitor and control related substances, ensuring product meets pharmacopeial specifications (USP, EP, BP).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing necessary impurity profiles and stability data.

Basic Information

Product Name	Hydrochlorothiazide Related Compound (n-[(2-Aminophenyl)Sulfonyl] Acetamide)
CAS No.	75304-18-6
Molecular Formula	C8H10N2O3S
Molecular Weight	214.24 g/mol
Synonyms	N-(2-Aminophenylsulfonyl)acetamide; 2-Amino-N-(2-aminophenylsulfonyl)acetamide (common misnomer); Hydrochlorothiazide Impurity; Hydrochlorothiazide Related Substance; HCTZ Related Compound; 2-Sulfamoylacetamilide derivative; Acetamide, N-[(2-aminophenyl)sulfonyl]-; 75304-18-6
EINECS	Contact for details

Quality Control

Every batch of this related compound is manufactured and analyzed under strict quality management systems. Specifications are aligned with pharmacopeial standards (USP/EP/BP) for related substances, with a typical purity of ≥95% (HPLC). Identity is confirmed by spectroscopic methods (IR, NMR, MS). A comprehensive Certificate of Analysis (COA), detailing batch-specific results for assay, related substances, residual solvents, and other critical parameters, is provided and traceable to primary standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The compound is light-sensitive (store away from light). Keep the container tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤ 1.0% w/w

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