Description

Rasagiline Impurity 17 is a designated impurity standard used in the analytical profiling and quality control of Rasagiline, a pharmaceutical active ingredient. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of Rasagiline-based medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Rasagiline mesylate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC or UPLC methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to confirm that Rasagiline batches meet stringent pharmacopeial (e.g., USP, EP) or internal purity specifications.
• Stability Studies: Used to track the formation of this specific impurity over time under various stress conditions (e.g., heat, humidity, light) to establish product shelf-life.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA, CTA) to support drug approval processes.
• Research & Development: Aids in synthetic route optimization and impurity fate mapping during the process development of Rasagiline.

Basic Information

Item	Detail
Product Name	Rasagiline Impurity 17
CAS No.	1276516-71-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rasagiline Related Compound 17; Rasagiline Impurity K; (1R)-N-(2-Propyn-1-yl)-2,3-dihydro-1H-inden-1-amine Impurity; 1H-Inden-1-amine, 2,3-dihydro-N-2-propynyl-, (1R)-, Impurity; Rasagiline EP Impurity K; Rasagiline USP Impurity; Azilect Impurity
EINECS	Contact for details

Quality Control

Our Rasagiline Impurity 17 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 1.0%

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