Description

Dexmedetomidine-025 is a high-purity pharmaceutical intermediate and reference standard, identified by CAS NO 2250242-52-3. It is a critical compound in the development and quality control of advanced sedative and analgesic medications. This material is essential for research institutions, pharmaceutical manufacturers, and analytical laboratories engaged in the synthesis and testing of active pharmaceutical ingredients (APIs) within the central nervous system therapeutic area.

Application

• Pharmaceutical Intermediate: A key building block in the synthesis of Dexmedetomidine hydrochloride and related API molecules.
• Analytical Reference Standard: Used for method development, validation, and quality control (QC) testing in HPLC, GC, and other chromatographic systems.
• Preclinical & Clinical Research: Serves as a starting material or standard in pharmacological studies and drug metabolism research.
• Impurity Profiling: Employed to identify, quantify, and qualify related substances and degradation products in final drug formulations.
• Regulatory Submissions: Provides certified material for stability studies and documentation required by agencies like the FDA and EMA.
• Custom Synthesis: A precursor for the development of novel analogs and derivatives with potential therapeutic applications.

Basic Information

Product Name	Dexmedetomidine-025
CAS No.	2250242-52-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dexmedetomidine Impurity 25; Dexmedetomidine Related Compound 25; Dexmedetomidine-025; Dexmedetomidine EP Impurity I; Dexmedetomidine USP Related Compound A; (S)-4-[1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole; Dexmedetomidine Specified Impurity
EINECS	Contact for details

Quality Control

Our Dexmedetomidine-025 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for pharmaceutical reference standards and intermediates. Certificates of Analysis (COA) with detailed chromatographic data are provided and can be tailored to meet specific pharmacopeial standards (USP, EP) upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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