Description

Budesonide-D8 is a deuterated analog of the potent glucocorticoid steroid budesonide, specifically labeled with eight deuterium atoms. This stable isotope-labeled compound is an essential internal standard for the precise quantification of budesonide in complex biological matrices using advanced analytical techniques like LC-MS/MS. 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 use of this high-purity standard ensures accurate and reliable data critical for regulatory submissions and quality control.

Application

• Internal Standard for Bioanalysis: Serves as a critical reference compound in the quantitative LC-MS/MS analysis of budesonide in plasma, serum, and other biological samples.
• Pharmacokinetic and Metabolism Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Drug Impurity Profiling and Characterization: Used as a marker in analytical methods development for identifying and quantifying related substances.
• Forensic and Doping Control Analysis: Supports precise measurement in specialized testing environments where high accuracy is mandated.
• Manufacturing Process Control: Can be utilized in quality control laboratories to monitor the synthesis and purity of non-labeled budesonide API.

Basic Information

Product Name	Budesonide-D8
CAS No.	1105542-94-6
Molecular Formula	C25H26D8O6
Molecular Weight	~434.55 g/mol
Synonyms	Budesonide-d8; 16α,17α-Butylidenebis(oxy)-11β,21-dihydroxy-1,4-pregnadiene-3,20-dione-d8; (11β,16α)-16,17-Butylidenebis(oxy)-11,21-dihydroxypregna-1,4-diene-3,20-dione-d8; Deuterated Budesonide; Budesonide (D8); Budesonide Internal Standard (D8); Budesonide-d8 Isotope
EINECS	Contact for details

Quality Control

Our Budesonide-D8 is manufactured under strict quality control protocols to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is characterized by advanced spectroscopic and chromatographic methods, including NMR, HPLC, and MS, to confirm identity, purity, and deuterium incorporation. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment, supporting compliance with GLP and ISO 17025 standards.

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 product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant and inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to expected mass spectrum
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D8)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms to structure
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 1.0%

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