Description

o-Desmethyl Apremilast Glucuronide Sodium Salt is a key metabolite and reference standard of the active pharmaceutical ingredient Apremilast. This compound is essential for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics (PK), and bioanalytical method validation. It is primarily utilized by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in the development and quality control of Apremilast-based therapies.

Application

• Pharmaceutical Reference Standard: Serves as a critical certified reference material (CRM) for the qualitative and quantitative analysis of Apremilast and its metabolites in biological matrices.
• Metabolite Identification & Profiling: Used in drug metabolism and pharmacokinetics (DMPK) studies to identify, characterize, and quantify the glucuronidated metabolite pathway.
• Bioanalytical Method Development: Essential for developing and validating sensitive and specific LC-MS/MS or HPLC-UV methods for therapeutic drug monitoring and clinical studies.
• Impurity Standard: Acts as a specified impurity standard in the quality control and stability testing of Apremilast drug substance and finished dosage forms to ensure product safety and efficacy.
• Preclinical & Clinical Research: Supports toxicology studies and clinical trial sample analysis to understand the full metabolic profile of Apremilast.

Basic Information

Product Name	o-Desmethyl Apremilast Glucuronide Sodium Salt
CAS No.	1384814-89-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	CC-10004 Metabolite M12 Sodium Salt; Apremilast Metabolite M12 Sodium Salt; Apremilast Glucuronide Sodium Salt; N-[2-[(1S)-1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl] glucuronide sodium salt; o-Desmethyl Apremilast β-D-Glucuronide Sodium Salt
EINECS	Contact for details

Quality Control

Our o-Desmethyl Apremilast Glucuronide Sodium Salt is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥95.0%
Water Content (KF)	Contact for details
Residual Solvents (GC)	Meets ICH guidelines

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