Description

Rasagiline Impurity 5 Mesylate is a high-purity reference standard specifically used in the pharmaceutical development and quality control of Rasagiline, a medication for Parkinson's disease. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient by accurately identifying and quantifying related substances. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Rasagiline API and finished dosage forms.
• Method Development and Validation: Used to develop, optimize, and validate analytical methods, particularly HPLC and UPLC, for impurity profiling.
• Quality Control & Batch Release: Serves as a system suitability standard and a calibrant in routine QC testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and control strategies in drug master files (DMFs).
• Stability Studies: Employed to monitor the formation of this specific impurity over time under various stress conditions (heat, light, humidity).
• Research and Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize purer batches of the active ingredient.

Basic Information

Product Name	Rasagiline Impurity 5 Mesylate
CAS No.	1312077-04-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rasagiline Related Compound 5 Mesylate; Rasagiline Mesylate Impurity 5; (1R)-N-(2-Propyn-1-yl)-2,3-dihydro-1H-inden-1-amine methanesulfonate (related impurity); Azilect Impurity 5 Mesylate; AGN-1135 Impurity 5 Mesylate; 1H-Inden-1-amine, 2,3-dihydro-N-2-propynyl-, (1R)-, methanesulfonate (salt); (R)-N-Propargyl-1-aminoindane mesylate impurity
EINECS	Contact for details

Quality Control

Our Rasagiline Impurity 5 Mesylate is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques like HPLC, NMR, and MS. We adhere to relevant ICH Q3A/B guidelines for impurities and can support compliance with cGMP standards for pharmaceutical reference materials.

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 under inert conditions or in a desiccator after opening to maintain stability and purity.

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)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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