Description

Brimonidine Impurity E is a designated impurity of the active pharmaceutical ingredient Brimonidine, a medication used to treat open-angle glaucoma and ocular hypertension. This compound is a critical reference standard for pharmaceutical research, development, and quality control, ensuring the purity and safety of the final drug product. It is primarily utilized by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Brimonidine Tartrate API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection and separation.
• Stability Studies & Forced Degradation: Employed as a marker to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure API and drug product batches meet stringent pharmacopeial (USP, EP) specifications for impurity limits.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA, CTA) with agencies like the FDA and EMA.
• Research & Development: Used in R&D to study the degradation pathways and chemical stability of Brimonidine, aiding in formulation optimization.

Basic Information

Product Name	Brimonidine Impurity E
CAS No.	168329-48-4
Molecular Formula	C11H10BrN5
Molecular Weight	292.14 g/mol
Synonyms	5-Bromo-6-(4,5-dihydro-1H-imidazol-2-ylamino)quinoxaline; Brimonidine Related Compound E; Brimonidine EP Impurity E; Brimonidine USP Impurity E; Brimonidine Degradation Product; 2-[(5-Bromoquinoxalin-6-yl)amino]-4,5-dihydro-1H-imidazole
EINECS	Contact for details

Quality Control

Our Brimonidine Impurity E is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data, ensuring traceability and compliance with ICH Q3B(R2) guidelines for impurities in new drug substances. The material is suitable for use as a pharmaceutical reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

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

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