Description

Hydrochlorothiazide Impurity 19 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing Hydrochlorothiazide. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Hydrochlorothiazide Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating chromatographic methods, such as HPLC and UPLC, to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency in pharmaceutical manufacturing.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) by providing definitive impurity characterization data required for drug approval.
• Stability Studies: Used to track the formation of degradation products in Hydrochlorothiazide formulations under various stress conditions.
• Research & Development: Supports pharmaceutical R&D in studying the degradation pathways and metabolism of Hydrochlorothiazide.

Basic Information

Product Name	Hydrochlorothiazide Impurity 19
CAS No.	5250-71-5
Molecular Formula	C₇H₈ClN₃O₄S₂
Molecular Weight	297.74 g/mol
Synonyms	6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide; Hydrochlorothiazide Related Compound; 6-Chloro-1,1-dioxo-3,4-dihydro-2H-1λ⁶,2,4-benzothiadiazine-7-sulfonamide; HCTZ Impurity 19; Hydrochlorothiazide EP Impurity H; Hydrochlorothiazide USP Related Compound; 5250-71-5; 6-Chloro-7-sulfamoyl-1,2,4-benzothiadiazine 1,1-dioxide
EINECS	Contact for details

Quality Control

Our Hydrochlorothiazide Impurity 19 is manufactured under strict quality control protocols to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is thoroughly characterized and tested using advanced analytical techniques, including HPLC, GC, MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, supporting compliance with ICH guidelines and pharmacopeial standards (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

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.