Description

Metolazone Impurity C is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Metolazone, a thiazide-like diuretic. It serves as a key marker for identifying and quantifying related substances during drug development and manufacturing. Pharmaceutical companies, contract research organizations (CROs), and quality control laboratories require this high-purity impurity standard to meet stringent regulatory requirements for drug substance and drug product release.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Metolazone Impurity C in API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or GC analytical methods to monitor impurities.
• Quality Control & Batch Release Testing: Used in routine QC testing to ensure Metolazone drug substances and products comply with pharmacopeial (e.g., USP, EP) and ICH Q3A/B impurity limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to demonstrate comprehensive impurity profiling.
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity formation pathways during the synthesis of Metolazone.

Basic Information

Product Name	Metolazone Impurity C
CAS No.	50869-25-5
Molecular Formula	C16H16ClN3O3S
Molecular Weight	365.84 g/mol
Synonyms	7-Chloro-1,2,3,4-tetrahydro-2-methyl-4-oxo-3-o-tolyl-6-quinazolinesulfonamide; 7-Chloro-2-methyl-4-oxo-3-(2-methylphenyl)-1,2,3,4-tetrahydro-6-quinazolinesulfonamide; Metolazone Related Compound C; Metolazone EP Impurity C; Metolazone USP Impurity C; 3-(2-Methylphenyl)-7-chloro-2-methyl-4-oxo-1,2,3,4-tetrahydroquinazoline-6-sulfonamide
EINECS	Contact for details

Quality Control

Our Metolazone Impurity C is manufactured and tested under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with ICH guidelines and relevant pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and all test results is provided with every shipment to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 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 unknown impurity: ≤ 0.10% 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.