Description

Rasagiline Impurity 2 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Rasagiline. 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 quality assurance of Rasagiline-based therapies for Parkinson's disease.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Rasagiline API batches.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC or UPLC methods.
• Quality Control & Batch Release Testing: Used in routine QC labs to monitor impurity levels against established specifications to ensure compliance with ICH guidelines.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• Research & Development: Supports process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Rasagiline Impurity 2
CAS No.	200628-33-7
Molecular Formula	C₁₂H₁₃N
Molecular Weight	171.24 g/mol
Synonyms	1H-Inden-1-amine, 2,3-dihydro-N-2-propynyl-; (R)-N-Prop-2-ynyl-2,3-dihydro-1H-inden-1-amine; Rasagiline Related Compound B; Rasagiline EP Impurity B; Rasagiline USP Impurity; Prop-2-yn-1-amine, N-[(1R)-2,3-dihydro-1H-inden-1-yl]-; UNII-9J2K7V3F3P
EINECS	Contact for details

Quality Control

Our Rasagiline Impurity 2 is manufactured and handled under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment, supporting compliance with cGMP and relevant pharmacopeial guidelines (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should 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)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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