Description

Piribedil Impurity 2 is a specified impurity of the active pharmaceutical ingredient Piribedil, a dopamine agonist used in the treatment of Parkinson's disease. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, quality control, and regulatory compliance. It is essential for analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical industry who require high-purity chemical reference materials to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Piribedil Impurity 2 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating chromatographic methods (HPLC, UPLC, GC) to monitor impurities during drug manufacturing.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Piribedil API and formulations meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity profiles.
• Regulatory Compliance & Submission: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed as an analytical marker to track the formation of degradation products in Piribedil under various stress conditions (heat, light, humidity).
• Research & Process Chemistry: Used in synthetic route development and process optimization to understand and minimize the formation of this specific impurity.

Basic Information

Product Name	Piribedil Impurity 2
CAS No.	50602-51-2
Molecular Formula	C16H18N4O2
Molecular Weight	298.34 g/mol
Synonyms	1-(3,4-Methylenedioxybenzyl)-4-(2-pyrimidinyl)piperazine; Piribedil Related Compound B; Piribedil EP Impurity B; Piribedil USP Impurity; Trivastal Impurity 2; 4-(Pyrimidin-2-yl)-1-[(1,3-benzodioxol-5-yl)methyl]piperazine; 2-[4-[(1,3-Benzodioxol-5-yl)methyl]-1-piperazinyl]pyrimidine
EINECS	Contact for details

Quality Control

Our Piribedil Impurity 2 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your quality and regulatory requirements.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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