Description

Rasagiline Impurity 1 CAS NO 17563-12-1 is a high-purity chemical reference standard used in the analytical profiling of the active pharmaceutical ingredient (API) Rasagiline. This compound is critical for ensuring the quality, safety, and efficacy of Rasagiline-based drug products by serving as a benchmark in impurity identification and quantification. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on method development, validation, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the analysis of Rasagiline mesylate API and finished dosage forms.
• Method Development and Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or GC analytical methods in accordance with ICH guidelines.
• Quality Control and Batch Release: Used in routine QC testing to monitor and control the level of this specific impurity during API synthesis and drug manufacturing.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing characterized impurity data for drug approval processes.
• Stability Studies: Employed to identify and quantify degradation products in forced degradation and long-term stability studies of Rasagiline formulations.
• Pharmacopeial Testing: Serves as a system suitability standard for tests specified in pharmacopeias like USP or EP monographs for Rasagiline.

Basic Information

Product Name	Rasagiline Impurity 1
CAS No.	17563-12-1
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 Impurity; Rasagiline Related Compound A; Rasagiline EP Impurity A; Rasagiline USP Impurity; Azilect Impurity 1; TVP-1012 Impurity
EINECS	Contact for details

Quality Control

Every batch of Rasagiline Impurity 1 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using techniques such as HPLC, GC-MS, NMR, and IR to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines. We support compliance with cGMP, ISO, and other relevant regulatory frameworks for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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