Description

Brimonidine Impurity 14 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical products containing brimonidine. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical testing laboratories involved in drug development, production, and quality assurance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Brimonidine Tartrate Active Pharmaceutical Ingredient (API) and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control (QC) Testing: Serves as a system suitability and calibration standard in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity characterization and control strategies as per ICH Q3A and Q3B guidelines.
• Stability Studies: Employed to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of brimonidine formulations.
• Research and Development: Used in R&D to study the degradation pathways and chemical behavior of brimonidine under various conditions.

Basic Information

Product Name	Brimonidine Impurity 14
CAS No.	934548-66-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Brimonidine Related Compound 14; Brimonidine EP Impurity D; Brimonidine USP Impurity; 5-Bromo-6-(imidazolidin-2-ylideneamino)quinoxaline; (E)-5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl)quinoxalin-6-amine; Brimonidine Impurity D; Brimonidine Process Impurity; Brimonidine Degradant
EINECS	Contact for details

Quality Control

Every batch of Brimonidine Impurity 14 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and accurate identification, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical methods is provided with each shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Handle and store in accordance with good laboratory practices to maintain stability and integrity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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