Description

Methyclothiazide Related Compound A (100 Mg) (4-Amino-6-Chloro-n-3-Methyl-m-Ben-Zenedisulfonamide) is a high-purity reference standard critical for analytical and quality control processes in pharmaceutical development. This compound is essential for ensuring the accuracy and reliability of impurity profiling and method validation for the diuretic drug Methyclothiazide. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in regulatory compliance, research, and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Methyclothiazide Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical system suitability component to develop, optimize, and validate chromatographic methods for purity and stability-indicating assays.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure drug substance and product specifications meet pharmacopeial standards (e.g., USP, EP).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity characterization data required by agencies like the FDA and EMA.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug shelf-life determination.
• Research & Development: Acts as a key intermediate or impurity marker in synthetic chemistry research and process development for thiazide diuretics.

Basic Information

Product Name	Methyclothiazide Related Compound A (100 Mg) (4-Amino-6-Chloro-n-3-Methyl-m-Ben-Zenedisulfonamide)
CAS No.	13659-98-8
Molecular Formula	C8H10ClN3O4S2
Molecular Weight	311.77 g/mol
Synonyms	4-Amino-6-chloro-1,3-benzenedisulfonamide, 3-methyl-; 4-Amino-6-chloro-N-3-methyl-m-benzenedisulfonamide; 6-Chloro-4-amino-1,3-benzenedisulfonamide, 3-methyl-; Methyclothiazide Impurity A; Methyclothiazide Related Substance A; 3-Methyl-4-amino-6-chloro-1,3-benzenedisulfonamide; Enduron Related Compound A
EINECS	Contact for details

Quality Control

This high-grade reference material is produced under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, NMR, and mass spectrometry to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided, listing batch-specific results for identity, assay, and impurity profiles. Our quality protocols are designed to support compliance with cGMP and relevant pharmacopeial guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) 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 powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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