Description

Rasagiline Impurity 4 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Rasagiline mesylate. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and production of Rasagiline-based therapies for Parkinson's disease.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Rasagiline mesylate API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Employed in routine QC testing to ensure API batches comply with stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA) to support drug approval processes.
• Research & Development: Serves as a key intermediate or marker in synthetic chemistry research for process optimization and impurity synthesis studies.

Basic Information

Product Name	Rasagiline Impurity 4
CAS No.	1175018-79-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rasagiline Related Compound 4; Rasagiline Impurity D; (1R)-N-(2,3-Dihydro-1H-inden-2-yl)-2,3-dihydro-1H-inden-1-amine; 1H-Inden-1-amine, N-2,3-dihydro-1H-inden-2-yl-2,3-dihydro-, (1R)-; Rasagiline Process Impurity; Azilect Impurity 4
EINECS	Contact for details

Quality Control

Our Rasagiline Impurity 4 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic confirmation (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your quality and regulatory requirements.

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 desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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