Description

Hydrochlorothiazide Impurity G is a recognized pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of Hydrochlorothiazide, a widely prescribed diuretic medication. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of Hydrochlorothiazide Impurity G in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Used in research and development to establish and validate chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control & Assurance: Essential for routine batch testing in pharmaceutical QC labs to monitor impurity levels and ensure compliance with ICH guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Employed to track the formation of this specific degradant under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control.

Basic Information

Product Name	Hydrochlorothiazide Impurity G
CAS No.	1025-75-8
Molecular Formula	C₇H₈ClN₃O₄S₂
Molecular Weight	297.75 g/mol
Synonyms	6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide; Hydrochlorothiazide Related Compound G; 6-Chloro-1,1-dioxo-3,4-dihydro-2H-1λ⁶,2,4-benzothiadiazine-7-sulfonamide; Hydrochlorothiazide EP Impurity G; Hydrochlorothiazide USP Related Compound G; HCTZ Impurity G; 1025-75-8
EINECS	Contact for details

Quality Control

Our Hydrochlorothiazide Impurity G is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency. Each lot is thoroughly characterized and tested against stringent specifications, including identity confirmation by spectroscopic methods and purity determination by HPLC. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled accordingly to maintain stability.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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