Description

Bumetanide Impurity 6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Bumetanide through precise identification and quantification of related substances. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in method development, validation, and quality control. The compound is supplied with comprehensive analytical data to support compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Bumetanide API and finished dosage forms.
• Analytical Method Development: Used to develop, optimize, and validate HPLC, UPLC, and GC methods for impurity profiling.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing identified impurity markers.
• Stability Studies: Employed as a marker compound to monitor the formation of degradation products in Bumetanide formulations under various stress conditions.
• Research & Development: Serves as a key intermediate or impurity for synthetic pathway studies and metabolic research related to Bumetanide.
• Pharmacopeial Testing: Used as a system suitability standard in tests specified by USP, EP, or other pharmacopeias for Bumetanide monographs.

Basic Information

Product Name	Bumetanide Impurity 6
CAS No.	1236290-34-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bumetanide Related Compound 6; Bumetanide Impurity F; Bumetanide EP Impurity F; Bumetanide USP Impurity; 3-(Aminosulfonyl)-5-(butylamino)-4-phenoxybenzoic acid impurity; 4-Phenoxy-3-sulfamoyl-5-(butylamino)benzoic acid impurity; Bumetanide Degradant
EINECS	Contact for details

Quality Control

Every batch of Bumetanide Impurity 6 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the exacting standards of pharmaceutical impurity supply, with testing typically including HPLC for assay and related substances, IR for identification, and residual solvent analysis. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against predefined specifications. We support compliance with cGMP, ICH Q3A/B, and relevant pharmacopeial guidelines (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). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants or inert atmosphere packaging.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 5.0%

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