Description

Rasagiline Impurity 1 Hcl is a high-purity chemical reference standard used in the research, development, and quality control of pharmaceutical products. This compound is critical for the accurate identification, quantification, and monitoring of a specific impurity in Rasagiline mesylate, an active pharmaceutical ingredient (API) used in the treatment of Parkinson's disease. It is an essential tool for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable and well-characterized impurities to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Rasagiline mesylate API and its finished dosage forms.
• Method Development and Validation: Crucial for developing and validating sensitive analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor impurity levels against established specifications to ensure batch-to-batch consistency.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity identification and control strategies.
• Stability Studies: Employed to track the formation of this specific impurity during forced degradation and long-term stability studies of Rasagiline products.
• Research and Development: Facilitates process chemistry research aimed at understanding and minimizing the formation of this impurity during API synthesis.

Basic Information

Item	Detail
Product Name	Rasagiline Impurity 1 Hcl
CAS No.	1175018-75-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rasagiline Related Compound 1 Hcl; Rasagiline Impurity A Hcl; (1R)-N-(2-Propyn-1-yl)-2,3-dihydro-1H-inden-1-amine Hydrochloride (Rasagiline Impurity); 1H-Inden-1-amine, 2,3-dihydro-N-2-propynyl-, (1R)-, hydrochloride; Rasagiline EP Impurity A Hcl; Rasagiline USP Impurity Hcl
EINECS	Contact for details

Quality Control

Every batch of Rasagiline Impurity 1 Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques like HPLC, GC, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines (e.g., USP, EP) where applicable.

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. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. The container should be stored in a cool, dry, well-ventilated area away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Water Content	≤ 5.0%
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.