Description

Brimonidine Tartrate Impurity 4 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the active pharmaceutical ingredient Brimonidine Tartrate. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is primarily used by research institutions, analytical laboratories, and pharmaceutical companies involved in the development and production of ophthalmic solutions.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of impurities in Brimonidine Tartrate API and finished drug products.
• Analytical Method Development: Used to develop and validate HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance: Essential for routine batch testing in GMP environments to monitor and control impurity levels against ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed in forced degradation and long-term stability studies to track impurity formation over time.
• Research & Development: Used in synthetic chemistry research to study the formation and fate of this specific impurity.

Basic Information

Product Name	Brimonidine Tartrate Impurity 4
CAS No.	182628-02-0
Molecular Formula	C11H10BrN5 • C4H6O6
Molecular Weight	442.24 g/mol
Synonyms	5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl)quinoxalin-6-amine tartrate; Brimonidine Related Compound 4; Brimonidine Impurity D; Brimonidine EP Impurity D; Brimonidine Tartrate EP Impurity D; ALPHAGAN Impurity 4; UK-14,304-18 Tartrate Impurity
EINECS	Contact for details

Quality Control

Every batch of Brimonidine Tartrate Impurity 4 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
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.