Description

Rasagiline Impurity 3 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 affairs professionals involved in the development and production of Rasagiline mesylate, a medication used in the treatment of Parkinson's disease.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Rasagiline API and finished dosage forms.
• Method Development and Validation: Essential for developing, optimizing, and validating stability-indicating analytical methods such as HPLC and UPLC.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels and ensure compliance with pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA) with agencies like the FDA and EMA.
• Research and Development: Supports synthetic route optimization and impurity fate and tolerance studies during API process development.

Basic Information

Product Name	Rasagiline Impurity 3
CAS No.	1175018-74-2
Molecular Formula	C₁₂H₁₃N
Molecular Weight	171.24 g/mol
Synonyms	1H-Inden-1-amine, 2,3-dihydro-N-2-propynyl-; (1H-Inden-1-yl)propargylamine; N-Propargyl-1-aminoindane; Rasagiline Related Compound C; Rasagiline Impurity C; AGN-1135 Impurity; TVP-1012 Impurity
EINECS	Contact for details

Quality Control

Every batch of Rasagiline Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming conformity to established specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
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.