Description

Brimonidine Related Impurity 3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Brimonidine drug substances and finished pharmaceutical products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in the production of ophthalmic medications.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Brimonidine Tartrate API and drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to establish impurity limits and control strategies.
• Stability Studies: Used to track the formation of degradation products in Brimonidine formulations under various stress conditions.
• Research & Development: Supports R&D activities in synthetic chemistry, metabolism studies, and toxicological evaluation of impurities.

Basic Information

Product Name	Brimonidine Related Impurity 3
CAS No.	135306-56-8
Molecular Formula	C11H10BrN5
Molecular Weight	292.14 g/mol
Synonyms	5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl)quinoxalin-6-amine; Brimonidine Impurity 3; Brimonidine EP Impurity C; Brimonidine USP Related Compound C; UK-14,304-18 Impurity; (6-Amino-5-bromoquinoxalin-2-yl)(4,5-dihydro-1H-imidazol-2-yl)amine; ALPHAGAN Impurity C
EINECS	Contact for details

Quality Control

Every batch of Brimonidine Related Impurity 3 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, meeting the requirements for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing results from advanced analytical techniques such as HPLC, NMR, and Mass Spectrometry. Our quality commitment aligns with cGMP principles and relevant pharmacopeial guidelines (USP, EP).

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 at 2-8°C. Handle the material in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
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.