Description

Rac cis-3-Hydroxy Glyburide-D3,13C is a high-purity, isotopically labeled internal standard critical for advanced analytical quantification. This compound is essential for ensuring the accuracy and reliability of mass spectrometry-based methods in pharmaceutical research and development. It is primarily used by analytical chemists, CROs, and pharmaceutical manufacturers engaged in method development, pharmacokinetic studies, and quality control for the antidiabetic agent glyburide.

Application

• Quantitative Bioanalysis: Serves as a stable isotope-labeled internal standard for the precise LC-MS/MS quantification of glyburide and its metabolites in complex biological matrices like plasma, serum, and urine.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and pre-clinical trials.
• Method Development and Validation: Used as a critical reference material to develop, optimize, and validate robust analytical methods, correcting for matrix effects and instrument variability.
• Drug Impurity Profiling and Metabolite Identification: Aids in the identification and quantification of related substances and hydroxylated metabolites of glyburide.
• Quality Control in Pharmaceutical Manufacturing: Supports assay and impurity testing of glyburide active pharmaceutical ingredients (APIs) and finished dosage forms.
• Regulatory Submissions: Provides the traceable, high-quality reference standard required for compliant data packages submitted to agencies like the FDA and EMA.

Basic Information

Product Name	Rac cis-3-Hydroxy Glyburide-D3,13C
CAS No.	1217848-91-3
Molecular Formula	C23D313C H24ClN3O6S
Molecular Weight	~ 508.5 g/mol (exact mass varies with isotopic enrichment)
Synonyms	3-Hydroxy Glyburide-d3-13C; Glyburide 3-hydroxy metabolite-d3-13C; 1-[[p-[2-(5-Chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea-3-hydroxy-d3-13C; 5-Chloro-N-[2-[4-[[[[(trans-4-methylcyclohexyl)amino]carbonyl]amino]sulfonyl]phenyl]ethyl]-2-methoxybenzamide-3-hydroxy-d3-13C; GLB-3-OH-d3-13C; Deuterated and 13C-labeled 3-Hydroxy Glyburide
EINECS	Contact for details

Quality Control

Every batch of Rac cis-3-Hydroxy Glyburide-D3,13C is manufactured and analyzed under strict quality systems. We provide comprehensive Certificates of Analysis (COA) detailing isotopic purity (chemical and isotopic), chromatographic purity, and identity confirmation. Our quality commitment ensures the material meets the stringent requirements for use as a certified reference standard in regulated environments, supporting GLP and GMP compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This compound is hygroscopic (moisture-sensitive). For long-term storage, consider desiccant and under an inert atmosphere to maintain stability and isotopic integrity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (MS)	≥ 99.0 atom % D; ≥ 99.0 atom % 13C
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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