Description

Pantoprazole-D6 is a deuterium-labeled analog of the proton pump inhibitor pantoprazole, serving as a critical internal standard for precise quantitative analysis. This high-purity stable isotope-labeled compound is essential for ensuring accuracy and reliability in mass spectrometry-based assays, eliminating variability and improving data integrity. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug metabolism, pharmacokinetic (DMPK) studies, and bioanalytical method development.

Application

• Internal Standard for LC-MS/MS: Used as a quantitative reference standard in liquid chromatography-tandem mass spectrometry for the accurate measurement of pantoprazole in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK): Essential for studying the absorption, distribution, metabolism, and excretion (ADME) profiles of pantoprazole in preclinical and clinical research.
• Bioanalytical Method Development and Validation: Critical for developing, validating, and transferring robust analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Clinical and Preclinical Studies: Enables precise quantification of pantoprazole plasma concentrations in pharmacokinetic and bioequivalence studies.
• Pharmaceutical Quality Control: Supports impurity profiling and assay verification of pantoprazole active pharmaceutical ingredients (APIs) and finished dosage forms.
• Metabolite Identification: Aids in the identification and quantification of pantoprazole metabolites using high-resolution mass spectrometry.

Basic Information

Product Name	Pantoprazole-D6
CAS No.	922727-65-9
Molecular Formula	C16H9D6F2N3O4S
Molecular Weight	385.40 g/mol
Synonyms	Pantoprazole-d6; 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl-d6)methyl]sulfinyl]-1H-benzimidazole; BY1023-d6; Pantozol-d6; Protonix-d6; Pantoprazole (hexadeuterated); SK&F96022-d6
EINECS	Contact for details

Quality Control

Our Pantoprazole-D6 is manufactured under strict quality management systems to ensure the highest isotopic and chemical purity required for analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), isotopic enrichment, and residual solvents. We support compliance with cGMP and ICH Q7 guidelines for active pharmaceutical ingredients, and specifications can be tailored to meet specific pharmacopeial or client requirements.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (deuterium incorporation)	≥ 98.0 atom % D
Chemical Purity (by HPLC)	≥ 99.0%
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.