Description

Vinpocetine Impurity C is a specified impurity used in the analytical profiling and quality control of Vinpocetine, a nootropic pharmaceutical agent. This high-purity reference standard is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Vinpocetine API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Vinpocetine under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Pharmacopoeial Testing: Used to ensure compliance with pharmacopoeial monographs (e.g., USP, EP) that set limits for related substances.
• Research & Development: Utilized in synthetic chemistry R&D to understand and control impurity formation during the manufacturing process.

Basic Information

Product Name	Vinpocetine Impurity C
CAS No.	70155-05-4
Molecular Formula	C21H26N2O2
Molecular Weight	338.45 g/mol
Synonyms	Ethyl apovincaminate Impurity C; (3α,16α)-Eburnamenine-14-carboxylic acid ethyl ester; Apovincaminic acid ethyl ester impurity C; 14-Ethoxycarbonyl-3,14-secoeburn-4(16)-en-3-oic acid methyl ester (isomer); Vinpocetine related compound C
EINECS	Contact for details

Quality Control

Every batch of Vinpocetine Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated analytical methods (e.g., HPLC, NMR, MS) to ensure they meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with stated specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to prevent degradation.

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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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