Description

Vinpocetine Impurity A is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Vinpocetine, a nootropic agent, by serving as a benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control units, and contract research organizations (CROs) focused on developing and manufacturing compliant active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Vinpocetine API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing, calibrating, and validating HPLC, UPLC, and GC analytical methods to meet ICH Q2(R1) guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor and control impurity levels, ensuring product consistency.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and demonstrate control strategies in accordance with ICH Q3A/B.
• Stability Studies: Used as a marker to track degradation products and assess the stability profile of Vinpocetine under various storage conditions.
• Research & Development: Facilitates chemical and pharmacological research into the metabolism, synthesis pathways, and degradation mechanisms of Vinpocetine.

Basic Information

Product Name	Vinpocetine Impurity A
CAS No.	68780-78-9
Molecular Formula	C22H26N2O2
Molecular Weight	350.46 g/mol
Synonyms	Apovincaminic Acid; (3α,16α)-Eburnamenine-14-carboxylic Acid; Eburnamenine-14-carboxylic Acid; Vincamine Impurity A; Apovincamine-14-carboxylic Acid; 14-Carboxyeburnamenine; 14-Carboxy-(3α,16α)-eburnamenine
EINECS	Contact for details

Quality Control

Every batch of Vinpocetine Impurity A is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Assay (HPLC)	97.0% - 103.0% (on anhydrous basis)

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