Description

Rasagiline Impurity 16 is a designated impurity of the active pharmaceutical ingredient Rasagiline, a selective monoamine oxidase-B (MAO-B) inhibitor. This compound is a critical reference standard used in the analytical development and quality control processes for Rasagiline and its pharmaceutical formulations. It is essential for pharmaceutical manufacturers and analytical laboratories focused on ensuring product purity, safety, and regulatory compliance. The primary application for this material is as a high-purity chromatographic standard in pharmaceutical research and development.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Rasagiline mesylate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate stability-indicating HPLC/UPLC methods for Rasagiline impurity profiling.
• Quality Control & Batch Release Testing: Employed as a system suitability standard in routine QC laboratories to monitor impurity levels and ensure batch-to-batch consistency.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (e.g., USP, EP) that specify impurity limits for Rasagiline.

Basic Information

Product Name	Rasagiline Impurity 16
CAS No.	1276516-51-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rasagiline Related Compound 16; Rasagiline Impurity J; 1H-Inden-1-amine, 2,3-dihydro-N-2-propynyl-, (1R)- (related stereoisomer or derivative); Rasagiline Process Impurity; Rasagiline Degradant; Azilect Impurity 16; AGN-1135 Impurity
EINECS	Contact for details

Quality Control

Our Rasagiline Impurity 16 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for use as a reference standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment. Our quality commitment aligns with cGMP principles for pharmaceutical impurities and reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the certificate of analysis. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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