Description

Metolazone Impurity E is a high-purity reference standard critical for analytical method development and quality control in pharmaceutical manufacturing. This compound is essential for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Metolazone by accurately identifying and quantifying related substances. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories engaged in research, development, and regulatory compliance activities.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of testing methods (HPLC, GC-MS) per ICH guidelines.
• Method Development & Validation: Used in developing and validating stability-indicating assay methods for Metolazone drug substances and finished dosage forms.
• Quality Control & Assurance: Enables precise identification and quantification of impurity E in Metolazone batches to ensure compliance with pharmacopeial specifications (USP, EP).
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to monitor impurity profiles over time.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Supports impurity profiling and route scouting during the synthetic process development of Metolazone.

Basic Information

Product Name	Metolazone Impurity E
CAS No.	4015-23-0
Molecular Formula	C₁₆H₁₆ClN₃O₃S
Molecular Weight	365.83 g/mol
Synonyms	7-Chloro-1,2,3,4-tetrahydro-2-methyl-4-oxo-3-o-tolyl-6-quinazolinesulfonamide; 7-Chloro-2-methyl-3-(2-methylphenyl)-4-oxo-1,2,3,4-tetrahydro-6-quinazolinesulfonamide; Metolazone Related Compound E; Metolazone EP Impurity E; Metolazone USP Impurity E
EINECS	Contact for details

Quality Control

Our Metolazone Impurity E is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your quality and regulatory documentation.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment 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)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
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.