Description

Detomidine Impurity B is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the veterinary sedative Detomidine by serving as a key marker for impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory bodies focused on veterinary medicine. The availability of this well-characterized impurity supports compliance with stringent pharmacopeial guidelines for impurity control.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Detomidine hydrochloride active pharmaceutical ingredient (API) and finished formulations.
• Analytical Method Development & Validation: Crucial for developing, optimizing, and validating stability-indicating HPLC or UPLC methods in accordance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels against established specifications, ensuring batch-to-batch consistency and compliance.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Research & Synthesis Monitoring: Serves as a benchmark in chemical synthesis to optimize reaction pathways and minimize the formation of this specific impurity during API manufacturing.

Basic Information

Product Name	Detomidine Impurity B
CAS No.	83902-12-9
Molecular Formula	C13H16N2
Molecular Weight	200.28 g/mol
Synonyms	4-(2,3-Dimethylphenyl)methyl-1H-imidazole; Detomidine Related Compound B; Detomidine EP Impurity B; Detomidine USP Impurity B; Dexmedetomidine Impurity B (Isomer); 1H-Imidazole, 4-[(2,3-dimethylphenyl)methyl]-; (2,3-Dimethylbenzyl)imidazole
EINECS	Contact for details

Quality Control

Every batch of Detomidine Impurity B (CAS 83902-12-9) is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting its use in GLP/GMP environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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