Description

Bumetanide-D5 Butyl Ester is a stable isotope-labeled analog of the potent loop diuretic bumetanide, specifically deuterated at five positions. This compound is an essential internal standard for the precise and accurate quantification of bumetanide in complex biological matrices using advanced analytical techniques. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in pharmacokinetic studies, bioequivalence testing, and drug metabolism research. The high chemical purity and isotopic enrichment are critical for ensuring reliable and reproducible mass spectrometry results.

Application

• Internal Standard for LC-MS/MS Analysis: Serves as a critical reference compound for the quantitative analysis of bumetanide in plasma, serum, and urine samples.
• Pharmacokinetic and Bioanalytical Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and preclinical trials.
• Drug Metabolism Research (DMPK): Used in studies to identify and quantify metabolites, supporting drug development and regulatory submissions.
• Forensic and Anti-Doping Analysis: Provides a definitive standard for the detection and confirmation of bumetanide in forensic toxicology and sports doping control.
• Method Development and Validation: Essential for developing, optimizing, and validating robust analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Quality Control in Pharmaceutical Manufacturing: Can be utilized in impurity profiling and stability-indicating assay methods for bumetanide drug substances and products.

Basic Information

Product Name	Bumetanide-D5 Butyl Ester
CAS No.	1216685-32-3
Molecular Formula	C17H15D5N2O5S
Molecular Weight	369.44 g/mol (for deuterated form)
Synonyms	3-(Aminosulfonyl)-5-(butylamino)-4-phenoxy-D5-benzoic Acid Butyl Ester; Bumetanide-d5 Butyl Ester; Bumetanide Butyl Ester-d5; [2H5]-Bumetanide Butyl Ester; 4-Phenoxy-3-(sulfamoylamino)-D5-benzoic Acid Butyl Ester; Bumetanide (Butyl Ester)-d5; Deuterated Bumetanide Butyl Ester (D5); Isotopically Labeled Bumetanide Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Bumetanide-D5 Butyl Ester is manufactured under strict quality management systems and undergoes comprehensive analytical characterization. We guarantee high isotopic purity (typically ≥98 atom % D) and chemical purity (≥95% by HPLC) to meet the exacting demands of quantitative bioanalysis. Certificates of Analysis (COA) are provided with each shipment, detailing results for assay, isotopic enrichment, identity confirmation, and purity by HPLC. Our quality commitment aligns with the standards expected for reference materials used in GLP and GMP environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. For long-term storage, consider desiccant and inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Isotopic Purity	≥ 98 atom % D
Chemical Purity (NMR)	Consistent with structure
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH limits

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