Description

Rasagiline Impurity 3 Hcl is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Rasagiline mesylate, an important medication for Parkinson's disease. It is primarily utilized by analytical chemists and quality assurance professionals in the pharmaceutical industry to monitor and control the impurity profile of the active pharmaceutical ingredient (API). Ensuring the integrity of this impurity standard is fundamental to drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Rasagiline mesylate API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure API and drug products meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Regulatory Submissions: Essential for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Stability Studies: Used as a marker to track impurity formation and degradation pathways in stability testing of Rasagiline formulations.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Rasagiline to minimize the formation of this specific impurity.

Basic Information

Product Name	Rasagiline Impurity 3 Hcl
CAS No.	1175018-80-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rasagiline Related Compound 3 Hcl; Rasagiline Impurity C Hcl; 1H-Inden-1-amine, 2,3-dihydro-N-2-propynyl-, hydrochloride (1:1); (R)-N-2-Propynyl-1-indanamine hydrochloride impurity; Rasagiline Hydrochloride Impurity 3
EINECS	Contact for details

Quality Control

Every batch of Rasagiline Impurity 3 Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods (IR, NMR) and purity assessment by advanced chromatographic techniques (HPLC). Certificates of Analysis (COA) containing detailed batch-specific results are available upon request.

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 must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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